Notices of Compliance, 2025
1,998 notices issued in 2025, newest first.
| Date | Products | Company | Submission |
|---|---|---|---|
| December 31, 2025 | RYBELSUS | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 31, 2025 | BOSULIF | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 31, 2025 | IPG-MONTELUKAST | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 31, 2025 | CLEVOR | Orion Corporation | New Drug Submission (NDS) · Other |
| December 30, 2025 | KIRSTY | Biocon Sdn.Bhd | Supplement to a New Drug Submission (SNDS) · Other |
| December 30, 2025 | ALUNBRIG | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| December 30, 2025 | BIO-METFORMIN | Biomed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| December 30, 2025 | M-DAPAGLIFLOZIN | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 29, 2025 | PRO-PRAVASTATIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 29, 2025 | ARSENIC TRIOXIDE FOR INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 29, 2025 | TRANDATE | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| December 29, 2025 | NRA-CANDESARTAN | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 29, 2025 | RIVA-ANASTROZOLE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 29, 2025 | NRA-APIXABAN TABLETS | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 29, 2025 | NB-ARIPIPRAZOLE | NB Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 29, 2025 | TECENTRIQ; TECENTRIQ SC | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 29, 2025 | MOVIPREP | Aralez Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 29, 2025 | AURO-NINTEDANIB | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 29, 2025 | CEFAZOLIN FOR INJECTION | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 29, 2025 | MAR-DONEPEZIL | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 24, 2025 | IBUPROFEN CAPSULES, 200 MG; IBUPROFEN CAPSULES, 400 MG | Catalent Ontario Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 24, 2025 | IMOVANE | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 24, 2025 | LEUCOVORIN CALCIUM INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 24, 2025 | TEVA-AMPHETAMINE XR | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 24, 2025 | CONTRAVE | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 24, 2025 | CREDELIO PLUS | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 24, 2025 | MEN'S ROGAINE; MEN'S ROGAINE FOAM 5%; WOMEN'S ROGAINE FOAM 5% | Kenvue Canada Inc. | New Drug Submission (NDS) · Admin |
| December 23, 2025 | BENLYSTA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 23, 2025 | AG-APIXABAN | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 23, 2025 | AG-DONEPEZIL | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 23, 2025 | VORICONAZOLE FOR INJECTION | Formative Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 23, 2025 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| December 23, 2025 | JERAYGO | Idorsia Pharmaceuticals Ltd | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 23, 2025 | TARO-ESCITALOPRAM | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 23, 2025 | EPIRUBICIN FOR INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 23, 2025 | AMIODARONE HYDROCHLORIDE FOR INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 23, 2025 | MELPHALAN FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 23, 2025 | PRO-CLARITHROMYCIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 23, 2025 | LOCACORTEN VIOFORM EARDROPS | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| December 23, 2025 | CETIRIZINE ORAL SOLUTION | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| December 23, 2025 | IBUPROFEN; IBUPROFEN CAPLETS | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 23, 2025 | TRAZIMERA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 23, 2025 | NRA-DAPAGLIFLOZIN | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 23, 2025 | RIVA APIXABAN | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 22, 2025 | SANDOZ VORICONAZOLE; VORICONAZOLE FOR INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 22, 2025 | FRAGMIN | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2025 | DRAXIMAGE MAA | Jubilant Draximage Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2025 | LOKELMA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2025 | SANDOZ IRBESARTAN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 22, 2025 | APO-METFORMIN ER | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 22, 2025 | PLOSBRIO | Novo Nordisk Canada Inc | New Drug Submission (NDS) · Labelling Only |
| December 22, 2025 | POVIZTRA | Novo Nordisk Canada Inc | New Drug Submission (NDS) · Labelling Only |
| December 22, 2025 | ONDANSETRON INJECTION USP; ONDANSETRON INJECTION USP (PRESERVATIVE FREE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 22, 2025 | CARBOPLATIN INJECTION | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2025 | MENVEO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2025 | SEHCAT | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2025 | REDDY-RIVAROXABAN | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 22, 2025 | APO-APIXABAN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 22, 2025 | EUTHASOL | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| December 19, 2025 | PROPOFOL INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 19, 2025 | PEGYLATED LIPOSOMAL DOXORUBICIN HYDROCHLORIDE FOR INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 19, 2025 | APO-BRIVARACETAM | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 19, 2025 | APO-GABAPENTIN; APO-GABAPENTIN TABLETS | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 19, 2025 | APO-TOPIRAMATE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 19, 2025 | LOCACORTEN VIOFORM | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| December 19, 2025 | TAPAZOLE | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| December 19, 2025 | PROPOFOL INJECTION | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 19, 2025 | XCOPRI | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| December 18, 2025 | BALVERSA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 18, 2025 | NEMLUVIO | Galderma Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 18, 2025 | AZILECT | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 18, 2025 | MAVIRET | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Priority |
| December 18, 2025 | TEVIMBRA | Beone Medicines I Gmbh | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 18, 2025 | ACYCLOVIR SODIUM INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 18, 2025 | PEPCID COMPLETE | Kenvue Canada Inc. | New Drug Submission (NDS) · Admin |
| December 18, 2025 | MEN'S MINOXIDIL FOAM; WOMEN'S MINOXIDIL FOAM | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 18, 2025 | ZDS-BRIVARACETAM | Zydus Lifesciences Limited | Abbreviated New Drug Submission (ANDS) · Other |
| December 17, 2025 | MINT-IRBESARTAN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 17, 2025 | TARO-IRBESARTAN | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 17, 2025 | ESTRADOT | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | SEASONALE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | DETROL LA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | TARO-RIVAROXABAN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 17, 2025 | GAMMAGARD LIQUID | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | GAMMAGARD S/D | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | HYQVIA | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | CUVITRU | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | ADVAGRAF | Astellas Pharma Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | PROGRAF | Astellas Pharma Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2025 | TEVA-EVEROLIMUS | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 17, 2025 | RIVA-AMLODIPINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 17, 2025 | GERMSTOPSQ | Envision Sq Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 16, 2025 | AURO-CLOZAPINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 16, 2025 | CABOMETYX | Ipsen Biopharmaceuticals Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 16, 2025 | NAPROSYN | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 16, 2025 | MYA | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 16, 2025 | VYLOY | Astellas Pharma Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 16, 2025 | JAMP FINGOLIMOD | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 16, 2025 | TRYNGOLZA | Theratechnologies Inc | New Drug Submission (NDS) · Priority-NAS |
| December 15, 2025 | VORICONAZOLE FOR INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 15, 2025 | MEROPENEM FOR INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 15, 2025 | VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 15, 2025 | AURO-DULOXETINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 15, 2025 | FLUOROURACIL INJECTION USP | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 14, 2025 | BAVENCIO | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | IPG-CELECOXIB | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | TEVA-PIOGLITAZONE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | PROPOFOL INJECTION | Baxter Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | MYLAN-TOPIRAMATE | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | BIMZELX | Ucb Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | AWIQLI | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | AMVUTTRA | Alnylam Netherlands B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | APO-GLYCOPYRRONIUM | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 12, 2025 | BAMBEVI | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | CYMBALTA | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2025 | JATENZO (TESTOSTERONE UNDECANOATE) | Tolmar International Ltd. | New Drug Submission (NDS) · Other |
| December 12, 2025 | PMS-SUGAMMADEX | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | AURO-ZIPRASIDONE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | JAMP LAMOTRIGINE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | TEVA-PROPOFOL | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 12, 2025 | TEVA-TOPIRAMATE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | APO-TRAZODONE; APO-TRAZODONE D | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 11, 2025 | APO-DESMOPRESSIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | VERMOX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 11, 2025 | PMS-FINGOLIMOD | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | AURO-GABAPENTIN; AURO-GABAPENTIN TABLETS | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | MEZAVANT | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| December 11, 2025 | LEUCOVORIN CALCIUM INJECTION | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 11, 2025 | AURO-BUSPIRONE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | PRAVASTATIN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 11, 2025 | DONEPEZIL | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 11, 2025 | SOLIQUA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 11, 2025 | APO-TIZANIDINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | AVIANE 21; AVIANE 28 | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 11, 2025 | FLUTREXIN | Modern Veterinary Therapeutics Llc | Abbreviated New Drug Submission (ANDS) · Other |
| December 10, 2025 | ABRILADA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2025 | WEGOVY | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| December 10, 2025 | ZYKADIA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2025 | ATGAM | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2025 | ACID CONTROLLER MAXIMUM STRENGTH | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 10, 2025 | AURO-FAMOTIDINE 10 MG; AURO-FAMOTIDINE 20 MG; AURO-FAMOTIDINE MINT 20 MG | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 10, 2025 | ANASTROZOLE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 10, 2025 | AG-CITALOPRAM TABLETS | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 10, 2025 | MAR-ANASTROZOLE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 10, 2025 | M-METHOTREXATE | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 9, 2025 | MINT-GABAPENTIN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 9, 2025 | PLENDIL | Glenwood Gmbh Pharmazeutische Erzeugnisse | Supplement to a New Drug Submission (SNDS) · Other |
| December 9, 2025 | CLIMARA 25; CLIMARA 50; CLIMARA 75 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 9, 2025 | OLESTYR | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 9, 2025 | RIVA-ALENDRONATE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 9, 2025 | ELFABRIO | Chiesi Farmaceutici S.P.A. | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 9, 2025 | AG-VALACYCLOVIR | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 9, 2025 | IMITREX; IMITREX DF | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 9, 2025 | MYLAN-AMLODIPINE/ATORVASTATIN | Mylan Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Admin |
| December 9, 2025 | JAMP GABAPENTIN CAPSULES | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 8, 2025 | MICRO SE | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2025 | SANDOZ POMALIDOMIDE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 5, 2025 | IMAAVY | Janssen Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 5, 2025 | SEPTRA PEDIATRIC ORAL SUSPENSION | Aspen Pharmacare Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| December 5, 2025 | BEXSERO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2025 | JAMP GATIFLOXACIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 5, 2025 | LIPIDIL EZ | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2025 | QINLOCK | Deciphera Pharmaceuticals. Llc | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2025 | PANTOPRAZOLE SODIUM FOR INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 5, 2025 | OKEDI | Laboratorios Farmaceuticos Rovi, S.A. | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2025 | ZURZUVAE | Biogen Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 5, 2025 | METHOTREXATE TABLETS, USP | Pfizer Canada Ulc | Abbreviated New Drug Submission (ANDS) · Other |
| December 5, 2025 | SANDOZ-CARBAMAZEPINE CR | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2025 | LEUCOVORIN CALCIUM INJECTION | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 5, 2025 | JAMP-CITALOPRAM | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 5, 2025 | PRO-AMOX-125; PRO-AMOX-250; PRO-AMOX-500 | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 4, 2025 | SANDOZ GUANFACINE XR | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 4, 2025 | TWYNEO | Searchlight Pharma Inc. | New Drug Submission (NDS) · Other |
| December 4, 2025 | CISATRACURIUM BESYLATE INJECTION USP MULTI-DOSE | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 4, 2025 | PAIN RELIEF GEL EXTRA STRENGTH | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 4, 2025 | TARO-ACITRETIN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 4, 2025 | PORTELA | Zoetis Canada Inc | New Drug Submission (NDS) · Other |
| December 3, 2025 | ULTOMIRIS | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| December 3, 2025 | WINREVAIR | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| December 3, 2025 | AMOXICILLIN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 3, 2025 | TEVA-ESOMEPRAZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 2, 2025 | RINVOQ | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | ELREXFIO | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | GLYCOPYRROLATE INJECTION USP | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP | Formative Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 2, 2025 | ACTIFEMME | Novast Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| December 2, 2025 | IMBRUVICA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | GILENYA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | DIPROSALIC | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | SUBLOCADE | Indivior Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | VOLIBRIS | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | LATANEO PF | Orimed Pharma Inc. | New Drug Submission (NDS) · Other |
| December 2, 2025 | JAMP RISPERIDONE TABLETS | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| December 2, 2025 | NYDA | G. Pohl-Boskamp GmbH & Co. KG | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | PERGOVERIS | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2025 | MONIMAX | Huvepharma Eood | New Drug Submission (NDS) · Other |
| December 1, 2025 | CELEXA | Lundbeck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 1, 2025 | JAMP NINTEDANIB | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 1, 2025 | JAMP NINTEDANIB | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2025 | ZIRABEV | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 28, 2025 | HYDREA | Cheplapharm Arzneimittel Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| November 28, 2025 | AURO-PREGABALIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2025 | CYTARABINE INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2025 | APO-SAXAGLIPTIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2025 | JAMP METHOTREXATE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| November 28, 2025 | ARAZLO | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 28, 2025 | DRAXIMAGE SESTAMIBI | Jubilant Draximage Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2025 | DULOXETINE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 28, 2025 | PANTOPRAZOLE FOR INJECTION | Eugia Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 28, 2025 | SANDOMIGRAN DS | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| November 28, 2025 | MAXIMUM STRENGTH PEPCID AC; PEPCID AC | Kenvue Canada Inc. | New Drug Submission (NDS) · Admin |
| November 28, 2025 | ANASTROZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 28, 2025 | IMODIUM COMPLETE | Kenvue Canada Inc. | New Drug Submission (NDS) · Admin |
| November 28, 2025 | RIVA-LATANOPROST | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 27, 2025 | NRA-CETIRIZINE TABLETS | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 27, 2025 | PRO-LEFLUNOMIDE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 27, 2025 | RADICAVA | Mitsubishi Tanabe Pharma Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| November 27, 2025 | FULVESTRANT INJECTION | Formative Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 26, 2025 | AURO-FLECAINIDE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 26, 2025 | JAMP PROPRANOLOL | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| November 26, 2025 | PMS-EDOXABAN | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 25, 2025 | ADDYI | Sprout Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| November 25, 2025 | NUBEQA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 25, 2025 | MEKINIST | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 25, 2025 | ALOG-PROPIVERINE; ALOG-PROPIVERINE PEDIATRIC | Analog Pharma Canada Inc. | New Drug Submission (NDS) · Admin |
| November 25, 2025 | RIVA-ROSUVASTATIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 25, 2025 | BUPROPION HCL SR | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 25, 2025 | APIXABAN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 25, 2025 | MAR-CETIRIZINE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 24, 2025 | EYDENZELT | Celltrion Inc. | New Drug Submission (NDS) · Other |
| November 24, 2025 | ZILBRYSQ | Ucb Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 24, 2025 | BRUKINSA | Beone Medicines I Gmbh | New Drug Submission (NDS) · Admin |
| November 24, 2025 | TUKYSA | Pfizer Canada Ulc | New Drug Submission (NDS) · Admin |
| November 24, 2025 | M-APIXABAN | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 21, 2025 | MENVEO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 21, 2025 | ZOLGENSMA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 21, 2025 | ROTATEQ | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 21, 2025 | OGIVRI | Biosimilar Collaborations Ireland Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 21, 2025 | DOXORUBICIN HYDROCHLORIDE INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 21, 2025 | WYNZORA | Knight Therapeutics Inc. | New Drug Submission (NDS) · Other |
| November 21, 2025 | PENNSAID | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| November 21, 2025 | NRA-CITALOPRAM | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 21, 2025 | PYZCHIVA; PYZCHIVA I.V. | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| November 21, 2025 | ADVIL HEADACHE & MIGRAINE CAPLETS; ADVIL HEADACHE & MIGRAINE EXTRA STRENGTH; ADVIL HEADACHE & MIGRAINE TABLETS | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| November 20, 2025 | LEVOCARNITINE INJECTION | Sola Pharmaceuticals Canada LP | Abbreviated New Drug Submission (ANDS) · Other |
| November 20, 2025 | PROHANCE | Bracco Imaging Canada | Supplement to a New Drug Submission (SNDS) · Other |
| November 20, 2025 | JAMP ANASTROZOLE TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 20, 2025 | APO-CLADRIBINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 19, 2025 | AHZANTIVE | Valorum Biologics Llc | New Drug Submission (NDS) · Other |
| November 19, 2025 | ZYTRAM XL | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| November 19, 2025 | BEXACAT | Elanco Canada Limited | New Drug Submission (NDS) · Other |
| November 18, 2025 | REMSIMA SC | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2025 | REMDANTRY | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2025 | DARZALEX SC | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2025 | ROFACT | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2025 | TEVA-CLOBETASOL | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2025 | PRO-AZITHROMYCINE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| November 18, 2025 | ACH-GABAPENTIN | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 18, 2025 | PRO-DAPAGLIFLOZIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 18, 2025 | M-ALENDRONATE | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 18, 2025 | CEFA-DRI | Boehringer Ingelheim Animal Health Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2025 | IMAVEROL | Audevard | New Drug Submission (NDS) · Admin |
| November 17, 2025 | MULTIHANCE | Bracco Imaging Canada | Supplement to a New Drug Submission (SNDS) · Other |
| November 17, 2025 | VELSIPITY | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 17, 2025 | TEVA-PAROXETINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 17, 2025 | ACCEL-DAPAGLIFLOZIN | Accel Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 17, 2025 | TREMFYA; TREMFYA ONE-PRESS | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 17, 2025 | SKYRIZI | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| November 16, 2025 | SANDOZ ATORVASTATIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 16, 2025 | APO-AMLODIPINE-ATORVASTATIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 16, 2025 | TEVA-IRBESARTAN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 16, 2025 | APO-DILTIAZ CD | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 16, 2025 | TARO-CARBAMAZEPINE; TARO-CARBAMAZEPINE CHEWABLE TABLETS | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 14, 2025 | BUTRANS | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| November 14, 2025 | NEORAL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 14, 2025 | NOROMBY; NOROMBY HP | Juno Pharmaceuticals Corp. | Supplement to a New Drug Submission (SNDS) · Other |
| November 14, 2025 | PAROXETINE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 14, 2025 | GANCICLOVIR FOR INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 14, 2025 | AZACITIDINE FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 14, 2025 | TARO-TRAMADOL ER | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 14, 2025 | JAMP ALENDRONATE SODIUM | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 14, 2025 | NILEMDO | Hls Therapeutics Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| November 14, 2025 | XELJANZ; XELJANZ XR | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 14, 2025 | ROSUVASTATIN | 10445517 Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| November 14, 2025 | APO-SITAGLIPTIN-METFORMIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 13, 2025 | CALCIMAR | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 13, 2025 | TNKASE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 13, 2025 | LUPRON DEPOT | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| November 13, 2025 | AMOXICILLIN; AMOXICILLIN (REDUCED-SUGAR) | Sanis Health Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 13, 2025 | STIVARGA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 12, 2025 | ZORYVE | Arcutis Canada, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 12, 2025 | ZENRELIA | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 11, 2025 | AURO-LACOSAMIDE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 11, 2025 | ACH-FINGOLIMOD | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 11, 2025 | ALTA-PANTOPRAZOLE | Altamed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 10, 2025 | MICRO CR | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 10, 2025 | VINBLASTINE SULPHATE INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 10, 2025 | KYZATREX | Marius Pharmaceuticals, Llc | New Drug Submission (NDS) · Other |
| November 10, 2025 | JAMP ATENOLOL TABLETS | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| November 10, 2025 | COSMEGEN | Recordati Rare Diseases Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 10, 2025 | PMSC-VENLAFAXINE XR | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 10, 2025 | NRA-DONEPEZIL | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 7, 2025 | MELVIZO | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | BERIPLEX P/N 1000; BERIPLEX P/N 500 | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | YESAFILI | Biosimilar Collaborations Ireland Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | LIVMOTY | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 7, 2025 | CASGEVY | Vertex Pharmaceuticals (Canada) Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | RUZURGI | Medunik Canada | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | SPC-FENOFIBRATE E | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 7, 2025 | ALDACTONE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | AA-DILTIAZ | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | AA-METHYLPHENIDATE SR | AA Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| November 7, 2025 | CLASTEON | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| November 7, 2025 | HYDROMORPHONE HYDROCHLORIDE INJECTION USP | Sterinova Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 7, 2025 | DAYVIGO | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2025 | VETMEDIN 1.25 MG CHEWABLE TABLETS; VETMEDIN 10 MG CHEWABLE TABLETS; VETMEDIN 2.5 MG CHEWABLE TABLETS; VETMEDIN 5 MG CHEWABLE TABLETS | Boehringer Ingelheim Animal Health Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 6, 2025 | RETEVMO | Eli Lilly Canada Inc | New Drug Submission (NDS) · Labelling Only |
| November 6, 2025 | ENTERIC COATED DAILY LOW DOSE ASA 81 MG | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 6, 2025 | 24HR NASAL ALLERGY RELIEF | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 5, 2025 | FINLIUS | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 5, 2025 | STELARA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 5, 2025 | SIMPONI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 5, 2025 | NOLVADEX-D | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 5, 2025 | CAMBIA | Aralez Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 5, 2025 | ORGOVYX | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| November 5, 2025 | ADVIL COLD & SINUS CONVENIENCE PACK | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | ORENCIA | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | OZEMPIC | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | KYMRIAH | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | RYBREVANT | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | DARZALEX; DARZALEX SC | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | MICRO +4 REGULAR STRENGTH | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | TYGACIL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | NUCYNTA EXTENDED-RELEASE | Endo Operations Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | ANTHIM | Elusys Therapeutics Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 4, 2025 | M-SITAGLIPTIN | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 4, 2025 | MINT-ROSUVASTATIN | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| November 3, 2025 | SANDOZ APIXABAN TABLET | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 3, 2025 | VYVGART SC | Argenx Bv | Supplement to a New Drug Submission (SNDS) · Other |
| November 3, 2025 | NRA-OLMESARTAN HCTZ | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 3, 2025 | NRA-QUETIAPINE | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 3, 2025 | NB-APIXABAN | NB Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 31, 2025 | MYLAN-LAMOTRIGINE | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 31, 2025 | OMLYCLO | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | PMS-GABAPENTIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 31, 2025 | SHINGRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | RYSTIGGO | Ucb Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | BAT | Emergent Biosolutions Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | SPC-CEFPROZIL | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 31, 2025 | PRZ-ISMN | Pharmaris Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 31, 2025 | JAMP-LISINOPRIL | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| October 31, 2025 | APO-DASATINIB TABLETS | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 31, 2025 | COMBOGESIC | Aft Pharmaceuticals (Can) Limited | New Drug Submission (NDS) · Admin |
| October 31, 2025 | JAMP-ANASTROZOLE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 31, 2025 | ALEVE BACK AND BODY PAIN; ALEVE CAPLETS; ALEVE LIQUID GELS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | MAXIDOL LIQUID GELS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | ALEVE NIGHTTIME | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2025 | BONQAT | Orion Corporation | New Drug Submission (NDS) · Other |
| October 30, 2025 | PRO-ANASTROZOLE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 30, 2025 | AG-ANASTROZOLE | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 30, 2025 | PRO-CEPHALEXIN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| October 30, 2025 | ENZEEVU | Sandoz Canada Inc. | New Drug Submission (NDS) · Other |
| October 29, 2025 | MAR-RANOLAZINE XR | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 29, 2025 | TRUQAP | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 29, 2025 | ACT ESCITALOPRAM ODT | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 29, 2025 | DAPAGLIFLOZIN | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| October 29, 2025 | SANDOZ FINGOLIMOD | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 29, 2025 | OPFOLDA | Amicus Therapeutics Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 29, 2025 | GLATECT | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 29, 2025 | DEPAKENE | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 29, 2025 | EPIVAL | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 29, 2025 | WELIREG | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 28, 2025 | MAR-BILASTINE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 28, 2025 | APO-SERTRALINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 28, 2025 | DOXYCYCLINE FOR INJECTION USP | Sterimax Inc. | New Drug Submission (NDS) · Other |
| October 28, 2025 | MOXIFLOXACIN INJECTION | Hikma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| October 28, 2025 | NAT-TRABECTEDIN | Natco Pharma (Canada) Inc | Abbreviated New Drug Submission (ANDS) · Other |
| October 28, 2025 | TEVA-LISINOPRIL/HCTZ (TYPE Z) | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 28, 2025 | ERTAPENEM FOR INJECTION | Hikma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 28, 2025 | MYFEMBREE | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| October 27, 2025 | JAMP VORICONAZOLE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | MINT-ITRACONAZOLE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | MINT-ATORVASTATIN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | DUPIXENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 27, 2025 | SANDOZ IRBESARTAN HCT | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | MYLAN-ATORVASTATIN | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | PIXXOSCAN | Ge Healthcare Canada Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | JAMP-AMOXICILLIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | ENHERTU | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 27, 2025 | HYPERRHO | Grifols Therapeutics Llc | Supplement to a New Drug Submission (SNDS) · Other |
| October 27, 2025 | MAR-ROSUVASTATIN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 27, 2025 | TEVA-CYPROTERONE / ETHINYL ESTRADIOL | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 27, 2025 | ESTROGEL | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | CEFTIN | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | PIQRAY | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | EDARBI | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | DOPTELET | Swedish Orphan Biovitrum Ab (Publ) | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | TIVICAY | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | DOVATO | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | SANDOZ LEVETIRACETAM | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 24, 2025 | TRIUMEQ | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | JULUCA | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | EDARBYCLOR | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 24, 2025 | LEQEMBI | Eisai Limited | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 24, 2025 | RIVA-FAMOTIDINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 24, 2025 | M-LATANOPROST | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 24, 2025 | M-CETIRIZINE | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 23, 2025 | DUTASTERIDE | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| October 23, 2025 | CIPRO ORAL SUSPENSION | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | MULTI 12 INJECTION | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | ZORYVE | Arcutis Canada, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | OMNISCAN | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | NRA-ROSUVASTATIN TABLETS | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 23, 2025 | TALVEY | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | NRA-CLOPIDOGREL | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 23, 2025 | VYALEV | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | MRESVIA | Moderna Biopharma Canada Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | CAMCEVI | Accord Healthcare Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2025 | VOYDEYA | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| October 22, 2025 | ODAN BUPROPION SR | Odan Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 22, 2025 | ZDS-MESALAMINE SUPPOSITORIES | Zydus Lifesciences Limited | Abbreviated New Drug Submission (ANDS) · Other |
| October 22, 2025 | LATANOPROST-TIMOLOL | Steri-Med Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 22, 2025 | OLOPATADINE | Steri-Med Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 22, 2025 | IPG-GABAPENTIN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 22, 2025 | GABAPENTIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 21, 2025 | DUPIXENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 21, 2025 | ALTUVIIIO | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 21, 2025 | AG-PRAVASTATIN TABLETS | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 21, 2025 | HYDROXYCHLOROQUINE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 21, 2025 | BRIMONIDINE | Steri-Med Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 21, 2025 | ZOPICLONE | Altamed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 21, 2025 | DULOXETINE | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 20, 2025 | DOTAREM | Guerbet | Supplement to a New Drug Submission (SNDS) · Other |
| October 20, 2025 | IXIFI | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 20, 2025 | M-BISOPROLOL | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 20, 2025 | JIVI | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 20, 2025 | AG TELMISARTAN-HCT | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 17, 2025 | YESINTEK; YESINTEK I.V. | Biosimilar Collaborations Ireland Limited | New Drug Submission (NDS) · Other |
| October 17, 2025 | ABRYSVO | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 17, 2025 | TEVA-LEFLUNOMIDE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 17, 2025 | LOQTORZI | Apotex Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 17, 2025 | JAYPIRCA | Eli Lilly Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 17, 2025 | JAMP ATORVASTATIN TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 17, 2025 | NITROJECT | Juno Pharma Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| October 17, 2025 | PEDIAPHARM NAPROXEN SUSPENSION | Medexus Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 17, 2025 | OCTASA | Tillotts Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| October 17, 2025 | OCTASA | Tillotts Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | M-M-R II | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | PROQUAD | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | GLATIRAMER ACETATE INJECTION | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | BAT | Emergent Biosolutions Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | AVTOZMA | Celltrion Inc. | New Drug Submission (NDS) · Other |
| October 16, 2025 | PMS-LAMOTRIGINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | PMS-LEVODOPA-CARBIDOPA | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | EUCRISA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | PREZCOBIX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | AURO-AZITHROMYCIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | TEVA-BUDESONIDE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | LYVDELZI | Gilead Sciences Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 16, 2025 | WAY-RISEDRONATE | Waymade Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 16, 2025 | JAMP-HYDRALAZINE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | WAYMADE-MARAVIROC | Waymade Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 16, 2025 | AURO-METHOTREXATE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | PRO-PAROXETINE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 16, 2025 | ZDS-LACOSAMIDE | Zydus Pharmaceuticals (Canada) Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| October 16, 2025 | GALANTAMINE ER | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| October 16, 2025 | TEVA-LEVOFLOXACIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 16, 2025 | VOLTAREN EMULGEL; VOLTAREN EMULGEL ACTIVE; VOLTAREN EMULGEL BACK & MUSCLE PAIN; VOLTAREN EMULGEL EXTRA STRENGTH; VOLTAREN EMULGEL JOINT PAIN EXTRA STRENGTH; VOLTAREN EMULGEL JOINT PAIN REGULAR STRENGTH | Haleon Canada ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Eugia Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 16, 2025 | NRA-ZOPICLONE | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 15, 2025 | APO-OLANZAPINE; APO-OLANZAPINE ODT | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 15, 2025 | DORZOLAMIDE-TIMOLOL | Steri-Med Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 15, 2025 | IBUPROFEN ORAL SUSPENSION, 100 MG / 5 ML | Strides Pharma Canada Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 15, 2025 | MEN'S ROGAINE; MEN'S ROGAINE FOAM 5%; WOMEN'S ROGAINE FOAM 5% | Johnson & Johnson Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | AA-VERAP | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| October 14, 2025 | CAPVAXIVE | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | ABEVMY | Biosimilar Collaborations Ireland Limited | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | INTUNIV XR | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | NUCYNTA IR | Endo Operations Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION - N; ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION - SP | Septodont | New Drug Submission (NDS) · Admin |
| October 14, 2025 | PMS-METHOTREXATE TABLETS | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 14, 2025 | WINREVAIR | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | KESIMPTA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 14, 2025 | LENIVIA | Zoetis Canada Inc | New Drug Submission (NDS) · Other |
| October 11, 2025 | SOLIQUA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | VECTIBIX | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | HYQVIA | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | CUVITRU | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | GAMMAGARD LIQUID | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | GLASSIA | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | REDDY-DASATINIB | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 10, 2025 | APO-OXYCODONE CR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 10, 2025 | PRO-DULOXETINE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 10, 2025 | TREPROSTINIL INJECTION | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 10, 2025 | ERIBULIN MESYLATE INJECTION | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| October 10, 2025 | PYLERA | Laboratoires Juvise Pharmaceuticals | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | PMS-TELMISARTAN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 10, 2025 | LATANOPROST | Steri-Med Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 10, 2025 | PEPCID COMPLETE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | ZOLINZA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2025 | TEVA-DESVENLAFAXINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 10, 2025 | COLD + SINUS PLUS | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 10, 2025 | M-PREGABALIN | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 10, 2025 | NRA-DOMPERIDONE | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 9, 2025 | OPUVIZ | Samsung Bioepis Co., Ltd | New Drug Submission (NDS) · Other |
| October 9, 2025 | TISSEEL | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| October 9, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 9, 2025 | OPZELURA | Incyte Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| October 9, 2025 | SPC-PANTOPRAZOLE | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 9, 2025 | ADCETRIS | Pfizer Canada Ulc | New Drug Submission (NDS) · Admin |
| October 8, 2025 | REACTINE ALLERGY LIQUID GELS | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 8, 2025 | MICRO CU | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 8, 2025 | TAMSULOSIN CR | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 8, 2025 | JAMP ATENOLOL TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 7, 2025 | GLYCOPYRROLATE INJECTION USP | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2025 | NORDITROPIN FLEXPRO | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2025 | SEPTRA INJECTION; SEPTRA PEDIATRIC SUSPENSION | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2025 | TARO-METHYLPREDNISOLONE INJECTION | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 7, 2025 | SPEVIGO | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2025 | LEVOTHYROXINE SODIUM FOR INJECTION | Avir Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 7, 2025 | JAMP CLOZAPINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| October 7, 2025 | SEPHIENCE | Ptc Therapeutics International Limited | New Drug Submission (NDS) · Priority-NAS |
| October 7, 2025 | SIMPARICA TRIO | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2025 | NB-RISEDRONATE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 7, 2025 | VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP | Generic Medical Partners Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 7, 2025 | PORTIA 21; PORTIA 28 | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 7, 2025 | SYNCROPROST | Ceva Animal Health Inc | Abbreviated New Drug Submission (ANDS) · Other |
| October 6, 2025 | CEFUROXIME FOR INJECTION, USP | Hikma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 6, 2025 | M-SILDENAFIL | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 6, 2025 | AG-LATANOPROST | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 5, 2025 | HALOPERIDOL LA | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 5, 2025 | M-ROSUVASTATIN | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 3, 2025 | BREYANZI | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| October 3, 2025 | M-ZOPICLONE | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 3, 2025 | CEFTIN | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 3, 2025 | MICAFUNGIN SODIUM FOR INJECTION | Omega Laboratories Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 3, 2025 | GLN-EDOXABAN | Glenmark Pharmaceuticals Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 3, 2025 | SANDOZ ABIRATERONE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 3, 2025 | NAPROXEN SODIUM TABLETS USP 220 MG | Rpg Life Sciences Limited | Abbreviated New Drug Submission (ANDS) · Other |
| October 3, 2025 | DUREZOL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 3, 2025 | MESNA FOR INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 3, 2025 | ELREXFIO | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 3, 2025 | TEVA-METFORMIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 3, 2025 | ZDS-LIOTHYRONINE | Zydus Lifesciences Limited | Abbreviated New Drug Submission (ANDS) · Other |
| October 2, 2025 | PMS-BILASTINE | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 2, 2025 | ARGATROBAN FOR INJECTION | Juno Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 2, 2025 | PRO-DONEPEZIL | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 2, 2025 | DORZOLAMIDE | Steri-Med Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 1, 2025 | BLEXTEN | Aralez Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 1, 2025 | TUKYSA | Seagen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 1, 2025 | SCEMBLIX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 1, 2025 | LUPIN-RIFAXIMIN | Lupin Pharma Canada Limited | New Drug Submission (NDS) · Admin |
| October 1, 2025 | JAMP-ZOPICLONE TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 1, 2025 | AG-ZOPICLONE | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 1, 2025 | AG-ANASTROZOLE TABLETS | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 1, 2025 | ITOVEBI | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| October 1, 2025 | TAGRISSO | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 1, 2025 | EMAVERT TABLETS | Felix Pharmaceuticals Pvt. Ltd. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 1, 2025 | PHEBURANE | Medunik Canada | Supplement to a New Drug Submission (SNDS) · Other |
| September 29, 2025 | PREVNAR 20 | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| September 29, 2025 | TEVA-FINASTERIDE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 29, 2025 | TARO-DASATINIB | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 29, 2025 | MNEXSPIKE | Moderna Biopharma Canada Corporation | New Drug Submission (NDS) · New Active Substance (NAS) |
| September 29, 2025 | TREOSULFAN FOR INJECTION | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 29, 2025 | HYOSCINE BUTYLBROMIDE INJECTION | The J. Molner Company Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 29, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP; DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | Juno Pharmaceuticals Corp. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 29, 2025 | AGAMREE | Kye Pharmaceuticals Inc. | New Drug Submission (NDS) · Priority-NAS |
| September 26, 2025 | RECOMBIVAX HB | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2025 | SPINRAZA | Biogen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2025 | APO-LEFLUNOMIDE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 26, 2025 | FAMVIR | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2025 | EPKINLY | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2025 | ABRYSVO | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2025 | MAR-IBUPROFEN XR | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 26, 2025 | ETIBI | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2025 | NRA-AMOXICILLIN | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 26, 2025 | FLUOXETINE-20; PRO-FLUOXETINE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| September 26, 2025 | ADVIL COLD & SINUS EXTRA STRENGTH LIQUI-GELS; ADVIL COLD & SINUS LIQUI-GELS; ADVIL COLD AND SINUS; ADVIL COLD AND SINUS DAYTIME; CHILDREN'S ADVIL COLD | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| September 26, 2025 | BRAVECTO QUANTUM | Intervet Canada Corp | New Drug Submission (NDS) · Other |
| September 25, 2025 | BIO-CITALOPRAM | Biomed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| September 25, 2025 | FLAGYSTATIN | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 25, 2025 | FLAGYL | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 25, 2025 | ROSUVASTATIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 24, 2025 | AFLIVU | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 24, 2025 | ALPHAGAN | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| September 24, 2025 | PAMIDRONATE DISODIUM FOR INJECTION | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| September 24, 2025 | TYRUKO | Polpharma Biologics S.A. | New Drug Submission (NDS) · Other |
| September 24, 2025 | CARVYKTI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 23, 2025 | APO-ARIPIPRAZOLE DEPOT | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 23, 2025 | SANDOZ LATANOPROST | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 23, 2025 | XARELTO | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 23, 2025 | PROVOCHOLINE | Methapharm Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 23, 2025 | APO-METHOTREXATE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 23, 2025 | FLUOXETINE CAPSULES | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 23, 2025 | DELSTRIGO | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 23, 2025 | PIFELTRO | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 22, 2025 | CITALOPRAM | Jubilant Generics Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 22, 2025 | NAROPIN | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 22, 2025 | APO-DIVALPROEX | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 22, 2025 | NB-DULOXETINE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 22, 2025 | PRO-DOMPERIDONE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| September 22, 2025 | TYLAN 200 | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | GARDASIL9 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | VENTOLIN DISKUS | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | ELOCOM | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | MICRO ZN | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | CONTRAVE | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | PADCEV | Pfizer Canada Ulc | New Drug Submission (NDS) · Admin |
| September 19, 2025 | NEULEPTIL | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | JAMP-ZOLMITRIPTAN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 19, 2025 | BUPROPION HYDROCHLORIDE XL | Yichang Humanwell Pharmaceuticals Co., Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| September 19, 2025 | TEVA-MYCOPHENOLATE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 19, 2025 | ALEVE NIGHTTIME | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 19, 2025 | REBIF | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| September 18, 2025 | APO-POSACONAZOLE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 18, 2025 | NB-LANSOPRAZOLE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 18, 2025 | MAROPIKARE TABLETS | Felix Pharmaceuticals Pvt. Ltd. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 17, 2025 | SANDOZ DORZOLAMIDE/TIMOLOL | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 17, 2025 | OSENVELT | Celltrion Inc. | New Drug Submission (NDS) · Other |
| September 17, 2025 | STOBOCLO | Celltrion Inc. | New Drug Submission (NDS) · Other |
| September 17, 2025 | MICAFUNGIN IN 0.9% SODIUM CHLORIDE INJECTION | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| September 17, 2025 | BIO-DOXYCYCLINE | Biomed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| September 17, 2025 | AURO-CANDESARTAN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 17, 2025 | AZACITIDINE FOR INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 16, 2025 | COLUMVI | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 16, 2025 | MAR-ZOPICLONE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 15, 2025 | COLUMVI | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 15, 2025 | VYVANSE | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| September 15, 2025 | PRO-ATENOLOL | Pro Doc Limitee | New Drug Submission (NDS) · Admin |
| September 15, 2025 | PRO-ATENOLOL | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| September 12, 2025 | TEVA-CARBAMAZEPINE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | APO-DAPAGLIFLOZIN-METFORMIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 12, 2025 | TEVA-FINGOLIMOD | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 12, 2025 | ORITINIV | Xediton Pharmaceuticals Inc. | New Drug Submission (NDS) · Priority-NAS |
| September 12, 2025 | BRENZYS | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | APO-LAMOTRIGINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 12, 2025 | SANDOZ LEVOFLOXACIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 12, 2025 | TRACLEER | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | PRADAXA | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | IBUPROFEN ORAL SUSPENSION USP | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | OPSUMIT | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | TEVA-SOLIFENACIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 12, 2025 | AMIODARONE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 12, 2025 | ALEVE BACK AND BODY PAIN; ALEVE CAPLETS; ALEVE LIQUID GELS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | NB-ROSUVASTATIN | NB Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 12, 2025 | ADDERALL XR | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| September 12, 2025 | LOTRIDERM | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 11, 2025 | MYLAN-FINGOLIMOD | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 11, 2025 | AURO-LAMOTRIGINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 11, 2025 | MINT-CARBAMAZEPINE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 11, 2025 | CALQUENCE | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 11, 2025 | ROSUVASTATIN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 10, 2025 | SAXENDA | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 10, 2025 | JAMP ARIPIPRAZOLE ORAL SOLUTION | JAMP Pharma Corporation | New Drug Submission (NDS) · Admin |
| September 10, 2025 | AG-CETIRIZINE | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 10, 2025 | JAMP OLOPATADINE 0.2% | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| September 10, 2025 | COLUMVI | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 10, 2025 | TARO-AMPHOTERICIN B LIPOSOMAL | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 9, 2025 | TARO-MELPHALAN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 9, 2025 | METHOTREXATE TABLETS, USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2025 | RINVOQ | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2025 | OMLYCLO | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2025 | MAR-ZOLMITRIPTAN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 9, 2025 | WOMEN'S MINOXIDIL FOAM | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 9, 2025 | MEN'S MINOXIDIL FOAM | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 9, 2025 | BACKUP PLAN ONESTEP | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2025 | M-EZETIMIBE | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 8, 2025 | JAMP-AMOXICILLIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 8, 2025 | SLENYTO | Neurim Pharmaceuticals Ltd. | New Drug Submission (NDS) · Other |
| September 5, 2025 | PMS-PALBOCICLIB | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 5, 2025 | VYVGART | Argenx Bv | Supplement to a New Drug Submission (SNDS) · Other |
| September 5, 2025 | ACCUTANE | Cheplapharm Schweiz Gmbh | New Drug Submission (NDS) · Labelling Only |
| September 5, 2025 | AURO-FLUOXETINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 5, 2025 | PANTOPRAZOLE FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 5, 2025 | SANDOZ ATORVASTATIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 5, 2025 | VLOOP | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| September 5, 2025 | LEUCOVORIN CALCIUM INJECTION, USP | Fresenius Kabi Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| September 5, 2025 | KADCYLA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 5, 2025 | NPLATE | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 4, 2025 | DAYBUE | Acadia Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 4, 2025 | GADOVIST 1.0 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 4, 2025 | MAGNEVIST | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 4, 2025 | JAMP-DOMPERIDONE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 3, 2025 | ARTISS | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2025 | TARO-BUPROPION XL | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 3, 2025 | PRO-ROSUVASTATIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 3, 2025 | NDUVRA | Organon Canada Inc. | New Drug Submission (NDS) · Admin |
| September 3, 2025 | NB-DAPAGLIFLOZIN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 3, 2025 | TREMFYA; TREMFYA I.V.; TREMFYA ONE-PRESS | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2025 | ADVIL MINI-GELS | Haleon Canada ULC | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2025 | TARO-PANTOPRAZOLE | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 2, 2025 | REMDANTRY | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 2, 2025 | INCLUNOX; INCLUNOX HP | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 2, 2025 | APO-TAMOX | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 2, 2025 | MAR-DOMPERIDONE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 2, 2025 | MINT-PERINDOPRIL | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 2, 2025 | ZOLEDRONIC ACID FOR INJECTION | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 29, 2025 | CUVITRU | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| August 29, 2025 | KINERET | Swedish Orphan Biovitrum Ab (Publ) | Supplement to a New Drug Submission (SNDS) · Other |
| August 29, 2025 | JAMP DAPAGLIFLOZIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 29, 2025 | MIDAZOLAM INJECTION USP | Sterinova Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 29, 2025 | DANTROLENE SODIUM FOR INJECTION, USP | Hikma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 29, 2025 | SANDOZ MIRABEGRON | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 29, 2025 | KETOROLAC TROMETHAMINE INJECTION, USP | Eugia Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 29, 2025 | SYNPHASIC 21 TABLETS; SYNPHASIC 28 TABLETS | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 29, 2025 | SELECT 1/35 (21-DAY); SELECT 1/35 (28-DAY) | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 29, 2025 | SUNLENCA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 29, 2025 | TEVA-MOMETASONE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 29, 2025 | AG-ROSUVASTATIN | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 29, 2025 | ELAHERE | AbbVie Corporation | New Drug Submission (NDS) · Priority-NAS |
| August 29, 2025 | VENTOLIN RESPIRATOR SOLUTION | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 28, 2025 | EVRYSDI | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 28, 2025 | COLD + SINUS | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 28, 2025 | ADVIL NIGHTTIME | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| August 28, 2025 | ROBAX PLATINUM | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| August 28, 2025 | LUMIGAN RC | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| August 28, 2025 | PMS-AZITHROMYCIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 28, 2025 | MIDAMOR | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 28, 2025 | SUGAMMADEX | Avir Pharma Inc | Abbreviated New Drug Submission (ANDS) · Other |
| August 28, 2025 | FLUMIST | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 28, 2025 | SYNOVEX CHOICE | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 28, 2025 | SYNOVEX PRIMER | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 27, 2025 | INFLUVAC TETRA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| August 27, 2025 | INFLUVAC | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| August 27, 2025 | OCTAGAM; OCTAGAM 5% | Octapharma Pharmazeutika Produktionsges M B H | Supplement to a New Drug Submission (SNDS) · Other |
| August 27, 2025 | ULTRAVIST 300; ULTRAVIST 370 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 27, 2025 | PRO-SITAGLIPTIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 27, 2025 | EPSOLAY | Searchlight Pharma Inc. | New Drug Submission (NDS) · Other |
| August 27, 2025 | APO-DOXEPIN | Apotex Inc. | New Drug Submission (NDS) · Admin |
| August 27, 2025 | ASA 81 MG | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 27, 2025 | CETIRIZINE; CETIRIZINE EXTRA STRENGTH | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 26, 2025 | FEMYSO | Lupin Pharma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| August 26, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 26, 2025 | UBRELVY | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| August 26, 2025 | WAINUA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 25, 2025 | TEVA-AMPHETAMINE XR | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 25, 2025 | SOTYKTU | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| August 25, 2025 | MIN-OVRAL 21; MIN-OVRAL 28 | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 25, 2025 | TEVA-LATANOPROST | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 25, 2025 | APO-CANDESARTAN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 25, 2025 | DONEPEZIL | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 25, 2025 | PONVORY | Vanda Pharmaceuticals Inc. | New Drug Submission (NDS) · Admin |
| August 25, 2025 | ANZUPGO | Leo Pharma Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 25, 2025 | SANDOZ SACUBITRIL-VALSARTAN | Sandoz Canada Inc. | New Drug Submission (NDS) · Admin |
| August 22, 2025 | MINT-ACYCLOVIR OINTMENT | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| August 22, 2025 | VENTOLIN HFA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 22, 2025 | TEVA-SUNITINIB | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 21, 2025 | ADVIL PEDIATRIC DROPS; ADVIL PEDIATRIC DROPS FEVER FROM COLDS OR FLU; CHILDREN'S ADVIL; CHILDREN'S ADVIL FEVER FROM COLDS OR FLU; CHILDREN’S ADVIL CHEWABLE TABLETS; JUNIOR STRENGTH ADVIL; JUNIOR STRENGTH ADVIL FEVER FROM COLDS OR FLU | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| August 21, 2025 | OPTIRAY 300; OPTIRAY 320; OPTIRAY 350 | Liebel-Flarsheim Company Llc | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | FLULAVAL TETRA | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | FLUZONE; FLUZONE HIGH-DOSE | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | FLUVIRAL | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | HALAVEN | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | RINVOQ | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | TRI-CIRA 21; TRI-CIRA 28 | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 21, 2025 | TRI-CIRA LO 21; TRI-CIRA LO 28 | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 21, 2025 | TRI-JORDYNA 21; TRI-JORDYNA 28 | Glenmark Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 21, 2025 | XULTOPHY | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | OZEMPIC | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | RYBELSUS | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | SPIKEVAX | Moderna Biopharma Canada Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2025 | VICTOZA | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 20, 2025 | FLUCELVAX | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 20, 2025 | FLUAD | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 20, 2025 | ACYCLOVIR SODIUM INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 20, 2025 | VACASAN | Parnell Technologies Pty Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| August 19, 2025 | TEVA-APIXABAN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 19, 2025 | GLN-GABAPENTIN | Glenmark Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 19, 2025 | REVESTIVE | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| August 19, 2025 | REVOLADE | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 19, 2025 | ODAN-PREGABALIN | Odan Laboratories Ltd. | New Drug Submission (NDS) · Other |
| August 19, 2025 | JAMP OXCARBAZEPINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| August 19, 2025 | ABILIFY ASIMTUFII | Otsuka Pharmaceutical Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| August 18, 2025 | NIMOTOP | Laboratoire X.0 | New Drug Submission (NDS) · Admin |
| August 18, 2025 | BRINEURA | Biomarin International Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 18, 2025 | NUBEQA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 18, 2025 | CYCLOPHOSPHAMIDE FOR INJECTION USP | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 18, 2025 | PMS-ALENDRONATE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 18, 2025 | PMS-ALENDRONATE-FC | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 18, 2025 | SITAGLIPTIN/METFORMIN | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 18, 2025 | COMIRNATY | Biontech Manufacturing Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| August 15, 2025 | ACH-HYDROXYCHLOROQUINE SULFATE | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 15, 2025 | CORIFACT 1250; CORIFACT 250 | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 15, 2025 | DUPIXENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 15, 2025 | NB-RIZATRIPTAN RDT | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 15, 2025 | AMTAGVI | Iovance Biotherapeutics, Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 15, 2025 | AURO-APIXABAN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 15, 2025 | NALOXONE HYDROCHLORIDE INJECTION USP; NALOXONE INJECTABLE | Hikma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 15, 2025 | APO-ESOMEPRAZOLE DELAYED-RELEASE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 15, 2025 | OCTREOTIDE INJECTION | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 15, 2025 | ABILIFY MAINTENA | Otsuka Pharmaceutical Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| August 14, 2025 | IXCHIQ | Valneva Austria Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| August 14, 2025 | GARDASIL 9 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 14, 2025 | ILLUCCIX | Telix Pharmaceuticals (Us) Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 14, 2025 | AURO-RIVAROXABAN | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 14, 2025 | ADVIL PLUS ACETAMINOPHEN | Haleon Canada ULC | Supplement to a New Drug Submission (SNDS) · Other |
| August 14, 2025 | PAIN RELIEVER & SLEEP AID | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 14, 2025 | ADVIL ARTHRITIS PAIN; ADVIL EXTRA STRENGTH LIQUI-GELS; ADVIL LIQUI-GELS; ADVIL MIGRAINE & HEADACHE | Haleon Canada ULC | New Drug Submission (NDS) · Labelling Only |
| August 13, 2025 | CRYSVITA | Kyowa Kirin, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 13, 2025 | COLUMVI | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 13, 2025 | OZEMPIC | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 13, 2025 | TEVA-DILTIAZEM HCL ER | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| August 13, 2025 | DUTASTERIDE | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 12, 2025 | GEMCITABINE INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 12, 2025 | AMOXICILLIN | Sivem Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2025 | MIEBO | Bausch & Lomb Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2025 | APO-DONEPEZIL | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 12, 2025 | APO-DORZO-TIMOP | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 12, 2025 | MAR-VENLAFAXINE XR | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 11, 2025 | VORICONAZOLE FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 11, 2025 | PERGOVERIS | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| August 11, 2025 | XGEVA | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 11, 2025 | JULUCA | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 11, 2025 | AURO-BRIVARACETAM | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 11, 2025 | REDDY-BOSUTINIB | Dr Reddys Laboratories Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| August 11, 2025 | ZOPICLONE | Sivem Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Admin |
| August 11, 2025 | APO-VALPROIC ACID; APO-VALPROIC ACID ORAL SOLUTION | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 11, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| August 8, 2025 | SANDOZ IRBESARTAN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 8, 2025 | STIVARGA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 8, 2025 | VINBLASTINE SULPHATE INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 8, 2025 | REDDY-SITAGLIPTIN | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 8, 2025 | GEMCITABINE FOR INJECTION | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 8, 2025 | RIVA-RUPATADINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 8, 2025 | HEPCLUDEX | Gilead Sciences Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| August 7, 2025 | PMS-OXYCODONE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 7, 2025 | IPG-QUETIAPINE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 7, 2025 | APO-AMPHETAMINE XR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 7, 2025 | SIMPONI; SIMPONI I.V. | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 7, 2025 | DIPROSONE | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 7, 2025 | SOLIRIS | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| August 7, 2025 | BREVICON 0.5/35 TABLETS (21 DAY PACK); BREVICON 1/35 TABLETS (21 DAY PACK) | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 6, 2025 | ANDEMBRY | Csl Behring Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 6, 2025 | VEKLURY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 6, 2025 | MINT-PREGABALIN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 6, 2025 | OMVOH | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 6, 2025 | TRULANCE | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 5, 2025 | APO-MYCOPHENOLIC ACID | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | MAR-DILTIAZEM T | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | SINCALIDE FOR INJECTION | Avir Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | HEMLIBRA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 5, 2025 | TARO-APIXABAN | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | AURO-RITONAVIR | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | AURO-VORICONAZOLE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | APO-DABIGATRAN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 5, 2025 | CYCLOPHOSPHAMIDE FOR INJECTION | Dr Reddys Laboratories Ltd | New Drug Submission (NDS) · Other |
| August 5, 2025 | BAVENCIO | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| August 1, 2025 | BLINCYTO | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 1, 2025 | RIVA-HYDROXYUREA | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 1, 2025 | CASGEVY | Vertex Pharmaceuticals (Canada) Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| August 1, 2025 | NB-IRBESARTAN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 1, 2025 | PHESGO | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 1, 2025 | ANDROGEL | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| August 1, 2025 | ZDS-VARENICLINE | Zydus Lifesciences Limited | Abbreviated New Drug Submission (ANDS) · Other |
| August 1, 2025 | PAXLOVID | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 1, 2025 | FENISOLVE | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 31, 2025 | ELTROXIN | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 31, 2025 | VENCLEXTA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| July 31, 2025 | RIVA-TELMISARTAN/AMLODIPINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 31, 2025 | EZETIMIBE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 31, 2025 | SYNJARDY | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| July 31, 2025 | JARDIANCE | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| July 31, 2025 | AG-PERINDOPRIL | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 31, 2025 | RISEDRONATE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 31, 2025 | LEUCOVORIN CALCIUM INJECTION USP | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| July 31, 2025 | CALQUENCE | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 31, 2025 | BRIDION | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 30, 2025 | TEVA-BICALUTAMIDE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 30, 2025 | MIRENA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2025 | ALLERGY RELIEF | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 29, 2025 | SPINRAZA | Biogen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2025 | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 29, 2025 | LOVASTATIN | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2025 | LEVULAN KERASTICK | Sun Pharmaceutical Industries Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 28, 2025 | RYBELSUS | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 28, 2025 | ODAN-FLUOXETINE | Odan Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 28, 2025 | BAVENCIO | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 28, 2025 | DIPRIVAN 1% | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 28, 2025 | AVAXIM | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 28, 2025 | POMALYST | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 28, 2025 | DONEPEZIL HYDROCHLORIDE TABLETS USP | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 28, 2025 | SUMATRIPTAN INJECTION, USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 28, 2025 | DYANAVEL XR | Kye Pharmaceuticals Inc. | New Drug Submission (NDS) · Other |
| July 28, 2025 | RIVA-FLUOXETINE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 25, 2025 | PRIVIGEN | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | VABYSMO | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | DIPROSONE | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | BRAFTOVI | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | SCEMBLIX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | AVALIDE | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | LUPRON DEPOT | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | NRA-TELMISARTAN/HCTZ | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 25, 2025 | AVAPRO | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | TERBINAFINE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 25, 2025 | PMSC-NIFEDIPINE ER | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 25, 2025 | EBIXA | Lundbeck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | RAPAMUNE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | KADIAN | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2025 | SOLVEZINE | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 25, 2025 | AG-TICAGRELOR | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 24, 2025 | MAXIDOL LIQUID GELS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 24, 2025 | APO-CETIRIZINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 24, 2025 | DIPROLENE | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 24, 2025 | VERZENIO | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 24, 2025 | APO-PRAVASTATIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 24, 2025 | TEVA-FLUVASTATIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 24, 2025 | ALLERGY RELIEF; EXTRA STRENGTH ALLERGY RELIEF | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 24, 2025 | DIARRHEA RELIEF LIQUID GELS | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 23, 2025 | JAMP FLUDROCORTISONE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 23, 2025 | CIPROFLOXACIN INTRAVENOUS INFUSION BP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 23, 2025 | SANDOZ ANASTROZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 23, 2025 | LYNKUET | Bayer Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 23, 2025 | CARNITOR | Leadiant Biosciences, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 23, 2025 | CADUET | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| July 23, 2025 | TOPAMAX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 23, 2025 | APO-CETIRIZINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 23, 2025 | CLARITHROMYCIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 23, 2025 | SOLVATRIM | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 22, 2025 | SPEVIGO | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2025 | JAMP MYCOPHENOLIC ACID | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 22, 2025 | JAMP APIXABAN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 22, 2025 | BUCCOLAM | Neuraxpharm Pharmaceuticals, S.L. | New Drug Submission (NDS) · Other |
| July 22, 2025 | LIPITOR | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2025 | MYSTEP | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 22, 2025 | JAMP CEFUROXIME | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 22, 2025 | M-PERINDOPRIL ERBUMINE | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 22, 2025 | APO-AZELASTINE/FLUTICASONE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 22, 2025 | BYLVAY | Medison Pharma Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2025 | APO-CLARITHROMYCIN; APO-CLARITHROMYCIN XL | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 22, 2025 | PROCYSBI | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2025 | THALOMID | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2025 | RETEVMO | Loxo Oncology Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2025 | PROPOFOL INJECTION | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 21, 2025 | AREXVY | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 21, 2025 | BLENREP | Glaxosmithkline Inc | New Drug Submission (NDS) · Other |
| July 21, 2025 | ALYFTREK | Vertex Pharmaceuticals (Canada) Incorporated | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 21, 2025 | SUNLENCA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 21, 2025 | 0.4% LIDOCAINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| July 21, 2025 | JAMP PERINDOPRIL | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 21, 2025 | NB-SITAGLIPTIN-METFORMIN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 21, 2025 | ETOPOSIDE INJECTION | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 18, 2025 | BLENREP | Glaxosmithkline Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 18, 2025 | TEZSPIRE | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 18, 2025 | FASENRA; FASENRA PEN | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 18, 2025 | CLOPIXOL; CLOPIXOL ACUPHASE; CLOPIXOL DEPOT | Lundbeck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 18, 2025 | JAMP-DONEPEZIL TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 17, 2025 | ACH-APIXABAN | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 17, 2025 | MYLAN-ATAZANAVIR | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 17, 2025 | MAR-MYCOPHENOLIC ACID | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 17, 2025 | IMFINZI | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| July 17, 2025 | VYVGART | Argenx Bv | Supplement to a New Drug Submission (SNDS) · Other |
| July 17, 2025 | SEASONIQUE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 17, 2025 | PROMETRIUM | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 17, 2025 | LIVMOTY | Janssen Inc. | New Drug Submission (NDS) · Labelling Only |
| July 17, 2025 | TPOXX | Siga Technologies, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 17, 2025 | LINCOMIX 44 | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| July 17, 2025 | LINCOMIX 110 | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| July 17, 2025 | BMD 110 G | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| July 16, 2025 | CLOTRIMADERM VAGINAL 3; CLOTRIMADERM VAGINAL 6 | Taro Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 16, 2025 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 16, 2025 | TEVA-TELMISARTAN HCTZ | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 16, 2025 | SEASONALE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 16, 2025 | GLEEVEC | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 16, 2025 | RYBREVANT | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 15, 2025 | ESCITALOPRAM | Jubilant Generics Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 15, 2025 | ACH-METHOTREXATE | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 15, 2025 | GLN-DAPAGLIFLOZIN | Glenmark Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 15, 2025 | AURO-DONEPEZIL | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 15, 2025 | JAMP ROSUVASTATIN TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 15, 2025 | JAMP DOXEPIN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| July 15, 2025 | APO-METHYLPHENIDATE CR | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 15, 2025 | FIROKARE CHEWABLE TABLETS | Felix Pharmaceuticals Pvt. Ltd. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 14, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 14, 2025 | IPG-DONEPEZIL | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 14, 2025 | JAMP APREMILAST | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 14, 2025 | XIPERE | Bausch & Lomb Inc. | New Drug Submission (NDS) · Other |
| July 11, 2025 | SEROSTIM | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 11, 2025 | SAIZEN | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 11, 2025 | POTELIGEO | Kyowa Kirin, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 11, 2025 | AMVUTTRA | Alnylam Netherlands B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| July 11, 2025 | LAMOTRIGINE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 11, 2025 | TEVA-ESCITALOPRAM | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 11, 2025 | NAT-DAPAGLIFLOZIN | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 10, 2025 | NUBEQA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 10, 2025 | MAR-DOXEPIN | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 10, 2025 | CLOZARIL | Hls Therapeutics Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 10, 2025 | HYDROMORPHONE HYDROCHLORIDE INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 10, 2025 | CLARITHROMYCIN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 9, 2025 | PROLEUKIN | Iovance Biotherapeutics Manufacturing Llc | New Drug Submission (NDS) · Admin |
| July 9, 2025 | PERIOGARD ALCOHOL FREE | Colgate-Palmolive Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 9, 2025 | CELEBREX | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| July 9, 2025 | SANDOZ ARIPIPRAZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 9, 2025 | LINCOMIX | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| July 9, 2025 | LINCO-SPECTIN 100 | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| July 8, 2025 | OMVOH | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 8, 2025 | PAVBLU | Amgen Canada Inc | New Drug Submission (NDS) · Other |
| July 8, 2025 | YAZ PLUS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 8, 2025 | RAN-CLARITHROMYCIN; TARO-CLARITHROMYCIN; TARO-CLARITHROMYCIN XL | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 8, 2025 | AURO-LEVOCARB | Auro Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2025 | TREMFYA; TREMFYA I.V.; TREMFYA ONE-PRESS | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2025 | YASMIN 21 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2025 | TRIQUILAR 21; TRIQUILAR 28 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2025 | YAZ | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2025 | ONIVYDE | Ipsen Biopharmaceuticals Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2025 | MINT-DAPAGLIFLOZIN | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| July 7, 2025 | RIVA-ZOPICLONE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 7, 2025 | 24 HOUR ALLERGY REMEDY | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 4, 2025 | TOBREX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 4, 2025 | IBRANCE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| July 4, 2025 | DEPO-MEDROL WITH LIDOCAINE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| July 4, 2025 | AMIVAS-ARTESUNATE | Amivas Ireland Ltd. | New Drug Submission (NDS) · Priority-NAS |
| July 4, 2025 | FULVESTRANT INJECTION | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 4, 2025 | COSENTYX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 4, 2025 | PRO-CETIRIZINE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 4, 2025 | PRO-AMOXI CLAV | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 3, 2025 | ENHERTU | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 3, 2025 | EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES; IBUPROFEN LIQUID GEL CAPSULES | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 3, 2025 | NUVAXOVID | Novavax Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 3, 2025 | PRUCALOPRIDE | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 3, 2025 | ISTURISA | Recordati Rare Diseases Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 2, 2025 | INFANRIX HEXA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 2, 2025 | INFANRIX-IPV/HIB | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 2, 2025 | BOOSTRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 2, 2025 | BOOSTRIX-POLIO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 2, 2025 | TRILEPTAL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 2, 2025 | TWINRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2025 | SKYRIZI | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2025 | AZACITIDINE FOR INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 30, 2025 | CONTINGENCY ONE | Mylan Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2025 | VOCABRIA | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2025 | CORZYNA | Kye Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2025 | GLICLAZIDE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 27, 2025 | ARANESP | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 27, 2025 | APO-HYDROXYQUINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 27, 2025 | ILUMYA | Sun Pharmaceutical Industries Limited | Supplement to a New Drug Submission (SNDS) · Other |
| June 27, 2025 | AURO-DAPAGLIFLOZIN / METFORMIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 27, 2025 | RINGZA | Duchesnay Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 27, 2025 | GLN-EZETIMIBE | Glenmark Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 27, 2025 | TEVA-TERIPARATIDE INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 27, 2025 | MINT-SITAGLIPTIN/METFORMIN | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| June 27, 2025 | PRO-METOPROLOL; PRO-METOPROLOL-L | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| June 27, 2025 | PREMARIN | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 26, 2025 | TECARTUS | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 26, 2025 | ALLEGRA 12 HOUR; ALLEGRA 24 HOUR; ALLEGRA HIVES | Sanofi Consumer Health Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 26, 2025 | AFLIVU | Apotex Inc. | New Drug Submission (NDS) · Other |
| June 26, 2025 | YESAFILI | Biosimilar Collaborations Ireland Limited | Supplement to a New Drug Submission (SNDS) · Other |
| June 26, 2025 | YESAFILI | Biosimilar Collaborations Ireland Limited | New Drug Submission (NDS) · Other |
| June 26, 2025 | TECVAYLI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 26, 2025 | SAIZEN | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 26, 2025 | MEN'S MINOXIDIL FOAM | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 26, 2025 | SPC-ROPINIROLE | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 26, 2025 | APO-DOXYLAMINE/B6 | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 26, 2025 | LYSODREN | Esteve Pharmaceuticals S.A. | New Drug Submission (NDS) · Labelling Only |
| June 25, 2025 | TEVA-LOPERAMIDE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| June 25, 2025 | EURO-CHLORHEXIDINE | Euro-Pharm International Canada Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| June 25, 2025 | PRIMAQUINE | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 25, 2025 | ANAPROX; ANAPROX DS | Searchlight Pharma Inc. | New Drug Submission (NDS) · Admin |
| June 25, 2025 | CABAZITAXEL FOR INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 25, 2025 | TARO-LISDEXAMFETAMINE; TARO-LISDEXAMFETAMINE CHEWABLE TABLETS | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 25, 2025 | NB-SITAGLIPTIN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 25, 2025 | JAMP VALACYCLOVIR | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 24, 2025 | YESCARTA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2025 | INNOHEP | Leo Pharma Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2025 | COSENTYX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2025 | SPECTRAMAST LC | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2025 | CALQUENCE | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2025 | ONGLYZA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2025 | BENAZEPRIL | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 24, 2025 | NRA-PERINDOPRIL | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 24, 2025 | METFORMIN ER | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 24, 2025 | METFORMIN ER | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 24, 2025 | APO-PENTOXIFYLLINE SR | Apotex Inc. | New Drug Submission (NDS) · Admin |
| June 24, 2025 | DULOXETINE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 23, 2025 | CAMZYOS | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 23, 2025 | LYNPARZA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 23, 2025 | JAMP TERAZOSIN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| June 20, 2025 | SANDOZ DAPAGLIFLOZIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 20, 2025 | SANDOZ APIXABAN TABLET | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 20, 2025 | IMJUDO | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 20, 2025 | CADUET | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| June 20, 2025 | CEFTAZIDIME FOR INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | ILARIS | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | YUFLYMA | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | COZAAR | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | HYZAAR; HYZAAR DS | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | OXLUMO | Alnylam Netherlands B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | TYLENOL DUAL ACTION ACETAMINOPHEN + IBUPROFEN | Kenvue Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 19, 2025 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | NB-BISOPROLOL TABLETS | NB Pharma Inc. | New Drug Submission (NDS) · Admin |
| June 19, 2025 | APO-PREGABALIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 19, 2025 | SOLU-MEDROL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | DEPO-MEDROL; DEPO-MEDROL (WITH PRESERVATIVE) | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2025 | AURO-TERBINAFINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 18, 2025 | CABAZITAXEL FOR INJECTION | Formative Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 18, 2025 | NRA-DOXYCYCLINE | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 18, 2025 | THALOMID | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 18, 2025 | REZUROCK | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 18, 2025 | GRANISETRON HYDROCHLORIDE INJECTION USP | Hikma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| June 18, 2025 | SPC-CEFPROZIL | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 18, 2025 | LONGAVO | Teva Canada Limited | New Drug Submission (NDS) · Other |
| June 17, 2025 | ASA DAILY LOW DOSE | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| June 17, 2025 | SKYRIZI | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 17, 2025 | REMIFENTANIL HYDROCHLORIDE FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 17, 2025 | RPC-NALTREXONE | Rusan Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 17, 2025 | MINT-LEVETIRACETAM SOLUTION | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| June 16, 2025 | TABRECTA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 16, 2025 | CAMCEVI | Accord Healthcare Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 16, 2025 | MAYZENT | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 16, 2025 | WELLBUTRIN SR | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 13, 2025 | UPLIZNA | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| June 13, 2025 | APO-ANASTROZOLE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 13, 2025 | SEAFORD NIFEDIPINE AND LIDOCAINE HYDROCHLORIDE CREAM | Seaford Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 13, 2025 | INNOHEP | Leo Pharma Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 13, 2025 | APO-DAPAGLIFLOZIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 13, 2025 | ACH-DONEPEZIL | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 13, 2025 | MINT-HYDROXYCHLOROQUINE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 13, 2025 | MEDROL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 12, 2025 | NRA-DULOXETINE | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 12, 2025 | QULIPTA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 12, 2025 | KISQALI | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 12, 2025 | VEMLIDY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | PRO-ELETRIPTAN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 11, 2025 | IMOVAX POLIO | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | BREYANZI | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | BERINERT 1500; BERINERT 500 | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | OZEMPIC | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | NEXIUM 24HR | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| June 11, 2025 | SPRYCEL | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | VIREAD | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | MEKINIST | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2025 | GEMCITABINE INJECTION | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 11, 2025 | JAMP GUANFACINE XR | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 11, 2025 | SURFACE CLEANER SANITIZER WIPES; EXELERATE MULTI-SURFACE SANITIZING WIPES | Ecolab Co. | New Drug Submission (NDS) · Other |
| June 10, 2025 | PMS-TERAZOSIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 10, 2025 | DUOBRII | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2025 | TAFINLAR | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2025 | AMOXICILLIN/CLAV | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 10, 2025 | LANCORA | Servier Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2025 | MIDAMOR | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 10, 2025 | BIKTARVY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2025 | FIRDAPSE | Kye Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 9, 2025 | MIDAZOLAM INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 9, 2025 | ACH-CANDESARTAN | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 9, 2025 | ZENHALE | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 9, 2025 | CEFTAZIDIME FOR INJECTION BP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 9, 2025 | VANFLYTA | Daiichi Sankyo Pharma Canada Limited | New Drug Submission (NDS) · New Active Substance (NAS) |
| June 6, 2025 | SPIKEVAX | Moderna Biopharma Canada Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 6, 2025 | ENGERIX-B | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 6, 2025 | HAVRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 6, 2025 | BACLOFEN INTRATHECAL | Avir Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 6, 2025 | SANDOZ LEFLUNOMIDE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 6, 2025 | WILATE | Octapharma Pharmazeutika Produktionsges M B H | Supplement to a New Drug Submission (SNDS) · Other |
| June 6, 2025 | TEVA-BUPROPION XL | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 6, 2025 | FRAGMIN | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 6, 2025 | SUPEUDOL 20 | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 6, 2025 | TARO-AMPHETAMINE XR | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 5, 2025 | APRETUDE | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2025 | NEXAVAR | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2025 | PLUSET | Alberta Veterinary Laboratories Ltd | New Drug Submission (NDS) · Other |
| June 4, 2025 | SKYRIZI | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 4, 2025 | SPORANOX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 4, 2025 | ACCEL-DAPAGLIFLOZIN | Accel Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 4, 2025 | PIASKY | Hoffmann-La Roche Limited | New Drug Submission (NDS) · New Active Substance (NAS) |
| June 4, 2025 | STEQEYMA; STEQEYMA I.V. | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 4, 2025 | ENABLEX | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2025 | COMIRNATY | Biontech Manufacturing Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2025 | SITAGLIPTIN | Jubilant Generics Limited | Abbreviated New Drug Submission (ANDS) · Other |
| June 3, 2025 | HUMATE-P | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2025 | AURO-CARVEDILOL | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 3, 2025 | NETSPOT | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2025 | SELENIOUS ACID INJECTION, USP | Fresenius Kabi Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| June 3, 2025 | NB-VALACYCLOVIR | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 3, 2025 | PRO-SIMVASTATIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 3, 2025 | ACCEL-ONDANSETRON ODT | Accel Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 3, 2025 | PLAN B | Foundation Consumer Healthcare, Llc | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2025 | MICONAZOLE NITRATE VAGINAL CREAM USP, 2% | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 3, 2025 | SPIKEVAX | Moderna Biopharma Canada Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2025 | NAT-SITAGLIPTIN | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 2, 2025 | DECCOX 6% | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 30, 2025 | AURO-DESMOPRESSIN | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 30, 2025 | MAROFLIX TABLETS | Felix Pharmaceuticals Pvt. Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| May 30, 2025 | AMOXICILLIN; AMOXICILLIN (SUGAR REDUCED) | Sanis Health Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| May 30, 2025 | AURO-AMOXICILLIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 30, 2025 | JAMP PRAVASTATIN TABLETS | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 30, 2025 | LANCORA | Servier Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 30, 2025 | RIVA-CLINDAMYCIN | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 30, 2025 | PENNSAID | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| May 30, 2025 | ISDN | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 29, 2025 | NORFLOXACIN | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 29, 2025 | TIMOLOL | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 29, 2025 | PRO-TELMISARTAN-HCTZ | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 28, 2025 | TARO-CEFPROZIL | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 28, 2025 | MGA 100 PREMIX | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 28, 2025 | DECCOX-M | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 28, 2025 | ROBENZ | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 28, 2025 | ZYDELIG | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2025 | TAMBOCOR | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2025 | SN-FENOFIBRATE E | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 28, 2025 | JAMP CLINDAMYCIN CAPSULES | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 28, 2025 | SOLUFY | Orimed Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 27, 2025 | ZOPICLONE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 27, 2025 | ARSENIC TRIOXIDE FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 27, 2025 | MIRENA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 27, 2025 | XOFLUZA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 27, 2025 | NB-ARIPIPRAZOLE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 27, 2025 | MINT-APIXABAN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | APO-CANDESARTAN/HCTZ | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | MAR-APIXABAN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | SANDOZ APIXABAN SDZ | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | LIDOCAINE HYDROCHLORIDE INJECTION | Laboratoire Aguettant | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | IPG-CETIRIZINE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | SANDOZ APIXABAN TABLET | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 26, 2025 | ZEJULA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 23, 2025 | TEVA-TELMISARTAN HCTZ | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | APO-TELMISARTAN-AMLODIPINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | FLUDARABINE PHOSPHATE FOR INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | TRANDATE | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| May 23, 2025 | DEXRAZOXANE FOR INJECTION | Hikma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| May 23, 2025 | SANDOZ RIVAROXABAN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | IBUPROFEN CAPSULES 200 MG | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | JAMP TELMISARTAN-HCT | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | CISATRACURIUM BESYLATE INJECTION, USP MULTI-DOSE; CISATRACURIUM BESYLATE INJECTION, USP SINGLE-DOSE | Hikma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| May 23, 2025 | MED-ROSUVASTATIN | Generic Medical Partners Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | QULIPTA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 23, 2025 | YESCARTA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 23, 2025 | APO-OLANZAPINE ODT | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | SPRAVATO | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 23, 2025 | VFEND | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| May 23, 2025 | IBUPROFEN CAPSULES, 200MG | Bionpharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 23, 2025 | ASA 81 MG | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 23, 2025 | WEGOVY | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 22, 2025 | REDESCA; REDESCA HP | Shenzhen Techdow Pharmaceutical Co., Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| May 22, 2025 | ADVIL 12 HOUR; ADVIL CAPLETS; ADVIL EXTRA STRENGTH CAPLETS; ADVIL MUSCLE AND JOINT; ADVIL TABLETS | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| May 22, 2025 | NEURONTIN | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| May 22, 2025 | CYSTADROPS | Recordati Rare Diseases Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 22, 2025 | MINT-ROSUVASTATIN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 22, 2025 | MITOMYCIN FOR INJECTION | Eugia Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 22, 2025 | IBUPROFEN CAPLETS; IBUPROFEN TABLETS | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 22, 2025 | NRA-TRAMADOL/ACET | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 22, 2025 | AVATEC 20 | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 22, 2025 | BOVATEC 20 | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 21, 2025 | MINJUVI | Incyte Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2025 | PYZCHIVA; PYZCHIVA IV | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2025 | BICNU | Marcan Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2025 | LYNPARZA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2025 | TECHNELITE | Lantheus Mi Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2025 | JAMP-RIZATRIPTAN ODT | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 21, 2025 | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 20, 2025 | FML | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 20, 2025 | SIGNIFOR | Recordati Rare Diseases Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 20, 2025 | KETOROLAC TROMETHAMINE INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 20, 2025 | TEVA-PANTOPRAZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 20, 2025 | PRO-ZOPICLONE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 16, 2025 | IPG-ANASTROZOLE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 16, 2025 | CARBETOCIN INJECTION | Juno Pharmaceuticals Corp. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 16, 2025 | REPATHA | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 16, 2025 | IPG-ROSUVASTATIN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 16, 2025 | ADVIL COLD & SINUS PLUS; ADVIL COLD AND SINUS NIGHTTIME; ADVIL COLD, SINUS & FLU EXTRA STRENGTH; CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| May 16, 2025 | MAR-LEFLUNOMIDE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 16, 2025 | STERILEX ULTRA-KLEEN SOLUTION | Sterilex Llc | New Drug Submission (NDS) · Other |
| May 16, 2025 | ACH-ROSUVASTATIN | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 16, 2025 | HEMGENIX | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 16, 2025 | AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 16, 2025 | PMS-PRAVASTATIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 16, 2025 | ZYBAN | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 16, 2025 | ALLEGRA-D | Sanofi Consumer Health Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 16, 2025 | TRIMBOW | Chiesi Farmaceutici S.P.A. | New Drug Submission (NDS) · Other |
| May 16, 2025 | PMS-METHADONE | Endo Operations Ltd. | New Drug Submission (NDS) · Other |
| May 16, 2025 | RIVA-ESOMEPRAZOLE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 16, 2025 | ACCUTANE ROCHE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2025 | ABSORICA LD | Sun Pharmaceutical Industries Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2025 | LENVIMA | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2025 | PMS-DONEPEZIL | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 15, 2025 | NEXGARD | Boehringer Ingelheim Animal Health Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2025 | SANDOZ AMIODARONE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 15, 2025 | LIBRAX | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2025 | AMIODARONE HYDROCHLORIDE FOR INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 15, 2025 | EPURIS | Cipher Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2025 | LEQVIO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2025 | AVAXIM | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2025 | SUGAMMADEX INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 14, 2025 | APO-HYDRALAZINE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2025 | TRODELVY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2025 | JAMP ANASTROZOLE TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 13, 2025 | SANDOZ AMPHETAMINE XR | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| May 13, 2025 | SMOFKABIVEN PERIPHERAL | Fresenius Kabi Canada Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| May 13, 2025 | TEVA-LACOSAMIDE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 13, 2025 | NOVAMOXIN; NOVAMOXIN (SUGAR REDUCED) | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 13, 2025 | LEUCOVORIN CALCIUM INJECTION | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 13, 2025 | TRIKAFTA | Vertex Pharmaceuticals (Canada) Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| May 13, 2025 | REDDY-EDOXABAN | Dr Reddys Laboratories Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| May 13, 2025 | ZEPBOUND KWIKPEN | Eli Lilly Canada Inc | New Drug Submission (NDS) · Other |
| May 12, 2025 | OCTREOTIDE FOR INJECTABLE SUSPENSION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 12, 2025 | KETOROLAC TROMETHAMINE INJECTION USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 12, 2025 | AUREOMYCIN 220 G | Phibro Animal Health Corporation | New Drug Submission (NDS) · Admin |
| May 9, 2025 | KEVZARA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 9, 2025 | TARO-DAPAGLIFLOZIN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 9, 2025 | SIGNIFOR LAR | Recordati Rare Diseases Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 9, 2025 | MUSE | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| May 8, 2025 | SANDOZ POLYTRIMETHOPRIM | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 8, 2025 | FLUOROURACIL INJECTION | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 8, 2025 | APO-DEXLANSOPRAZOLE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 8, 2025 | FLUMAZENIL INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 8, 2025 | ANDROCUR; ANDROCUR DEPOT | Amdipharm Limited | New Drug Submission (NDS) · Admin |
| May 8, 2025 | HARVONI | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 8, 2025 | SOVALDI | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 8, 2025 | FLAGYSTATIN | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 8, 2025 | STRIBILD | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 8, 2025 | FLAGYL | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2025 | RENFLEXIS | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2025 | TARO-ROSUVASTATIN | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 7, 2025 | SANDOZ DULOXETINE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 7, 2025 | AURO-TELMISARTAN HCTZ | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 7, 2025 | ENBREL | Immunex Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2025 | MRESVIA | Moderna Biopharma Canada Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2025 | AG-DAPAGLIFLOZIN | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 7, 2025 | OCALIVA | Advanz Pharma Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2025 | M-ESCITALOPRAM | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 7, 2025 | MINT-CETIRIZINE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 7, 2025 | ORLADEYO | Biocryst Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2025 | AUGTYRO | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · New Active Substance (NAS) |
| May 7, 2025 | AURO-ESLICARBAZEPINE | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 6, 2025 | IBUPROFEN LIQUID GEL | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 6, 2025 | SEEBRI BREEZHALER | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2025 | TEVA-DEXTROAMPHETAMINE SR | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2025 | MINT-BETAHISTINE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 6, 2025 | APO-PAROXETINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 5, 2025 | MED-OLOPATADINE | Generic Medical Partners Inc | Abbreviated New Drug Submission (ANDS) · Other |
| May 5, 2025 | TEVA-EDOXABAN | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| May 5, 2025 | JAMP EDOXABAN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 5, 2025 | PRO-EDOXABAN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| May 5, 2025 | SANDOZ EDOXABAN | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 5, 2025 | TZIELD | Sanofi-Aventis Canada Inc. | New Drug Submission (NDS) · Priority-NAS |
| May 2, 2025 | BYOOVIZ | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| May 2, 2025 | SANDOZ BRIMONIDINE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 2, 2025 | ITULATEK | Alk-Abello Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 2, 2025 | HERCEPTIN; HERCEPTIN SC | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 2, 2025 | EYLEA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 2, 2025 | COMBIGAN | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 2, 2025 | ACULAR | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 2, 2025 | TARO-PALBOCICLIB | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 2, 2025 | NRA-PRAVASTATIN | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 2, 2025 | IPG-ZOPICLONE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 1, 2025 | TECVAYLI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 1, 2025 | CEQUA | Sun Pharmaceutical Industries Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 1, 2025 | OPDIVO SC | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| May 1, 2025 | NORDIMET | Nordic Group B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| May 1, 2025 | CAPRELSA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 1, 2025 | MINT-EZETIMIBE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 1, 2025 | AG-RIZATRIPTAN ODT | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 1, 2025 | MEFLOQUINE | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 1, 2025 | LOCACORTEN VIOFORM EARDROPS | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| May 1, 2025 | PMS-IVERMECTIN | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| May 1, 2025 | TELMISARTAN/HCTZ | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 1, 2025 | PRID DELTA | Ceva Animal Health Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2025 | KENGREXAL | Chiesi Farmaceutici S.P.A. | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2025 | PMS-ROSUVASTATIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 30, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION USP; DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | Hikma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 30, 2025 | APO-TRIAZIDE TABLETS | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2025 | SUBLOCADE | Indivior Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2025 | RINVOQ | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2025 | FLORINEF | Endo Operations Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2025 | PRO-CYCLOBENZAPRINE | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| April 29, 2025 | SANDOZ ROSUVASTATIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | LYNPARZA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 29, 2025 | CRINONE | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| April 29, 2025 | CAMCEVI | Accord Healthcare Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 29, 2025 | JAMP PAROXETINE TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | PMS-TERIFLUNOMIDE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | TEVA-DOXYLAMINE/PYRIDOXINE DR | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | TEVA-MIRTAZAPINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | PANTOPRAZOLE FOR INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | NB-PANTOPRAZOLE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 29, 2025 | TEGRETOL; TEGRETOL CR; TEGRETOL SUSPENSION | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 29, 2025 | MINT-ANASTROZOLE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 29, 2025 | AURO-ROSUVASTATIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 28, 2025 | ACID CONTROLLER MAXIMUM STRENGTH | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 28, 2025 | ZOPICLONE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 28, 2025 | ADVIL ARTHRITIS PAIN; ADVIL EXTRA STRENGTH LIQUI-GELS; ADVIL LIQUI-GELS | Haleon Canada ULC | New Drug Submission (NDS) · Admin |
| April 28, 2025 | LEUCOVORIN CALCIUM INJECTION USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 28, 2025 | TORADOL IM | Atnahs Pharma Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 25, 2025 | TARO-ANASTROZOLE | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 25, 2025 | COMIRNATY | Biontech Manufacturing Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| April 25, 2025 | LUPIN-TOLVAPTAN | Lupin Pharma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| April 25, 2025 | DUAVIVE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 25, 2025 | TEVA-ROSUVASTATIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 25, 2025 | IQIRVO | Ipsen Biopharmaceuticals Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 25, 2025 | RYSTIGGO | Ucb Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 24, 2025 | DOCETAXEL INJECTION | Biolyse Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 24, 2025 | NAPROSYN | Searchlight Pharma Inc. | New Drug Submission (NDS) · Admin |
| April 24, 2025 | LABETALOL HYDROCHLORIDE INJECTION IN 0.72% SODIUM CHLORIDE; LABETALOL HYDROCHLORIDE INJECTION IN 5% DEXTROSE | Hikma Canada Limited | New Drug Submission (NDS) · Other |
| April 24, 2025 | SANDOZ RABEPRAZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 24, 2025 | SANDOZ ESTRADIOL DERM 100; SANDOZ ESTRADIOL DERM 50; SANDOZ ESTRADIOL DERM 75 | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 24, 2025 | HYDROMORPHONE HYDROCHLORIDE INJECTION USP | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 24, 2025 | ALEMBIC-TELMISARTAN | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 24, 2025 | APO-CITALOPRAM | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 23, 2025 | NIMENRIX | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 23, 2025 | TAGRISSO | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| April 23, 2025 | ADVIL COLD & SINUS EXTRA STRENGTH LIQUI-GELS; ADVIL COLD & SINUS LIQUI-GELS; ADVIL COLD AND SINUS; ADVIL COLD AND SINUS DAYTIME; CHILDREN'S ADVIL COLD | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 23, 2025 | JAMP EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 23, 2025 | ONPATTRO | Alnylam Netherlands B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| April 22, 2025 | BAVENCIO | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| April 22, 2025 | TEVA-MORPHINE SR | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 22, 2025 | PRADAXA | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| April 22, 2025 | GARDASIL 9 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 22, 2025 | TARO-MEDROXYPROGESTERONE INJECTION | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 22, 2025 | MEROPENEM FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 22, 2025 | IPG-DOMPERIDONE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 20, 2025 | JAMP CETIRIZINE TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 20, 2025 | KISQALI | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | PMS-ANASTROZOLE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 17, 2025 | TEPEZZA | Amgen Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 17, 2025 | SARCLISA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | PMS-DAPAGLIFLOZIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 17, 2025 | PRO-BACLOFEN | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| April 17, 2025 | ZOLGENSMA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | ADVIL HEADACHE & MIGRAINE CAPLETS; ADVIL HEADACHE & MIGRAINE EXTRA STRENGTH; ADVIL HEADACHE & MIGRAINE TABLETS | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | OPTIRAY 300; OPTIRAY 320; OPTIRAY 350; OPTIRAY ULTRAJECT 300; OPTIRAY ULTRAJECT 320; OPTIRAY ULTRAJECT 350 | Liebel-Flarsheim Company Llc | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | MEN'S MINOXIDIL FOAM | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 17, 2025 | CEREZYME | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | GILENYA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2025 | SANDOZ LATANOPROST | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 17, 2025 | CLARITHROMYCIN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 17, 2025 | ACT LEVOFLOXACIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 17, 2025 | EZETIMIBE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 17, 2025 | PRO-PRAVASTATIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 17, 2025 | PROCYSBI | Amgen Canada Inc | New Drug Submission (NDS) · Admin |
| April 17, 2025 | JAMP ONDANSETRON TABLETS | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| April 16, 2025 | SANDOZ TACROLIMUS XR | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 16, 2025 | GADOVIST 1.0 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 16, 2025 | PRIMOVIST | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 16, 2025 | IBUPROFEN ORAL SUSPENSION, 100 MG / 5 ML | Strides Pharma Canada Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 16, 2025 | SANDOZ TACROLIMUS | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 16, 2025 | COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 16, 2025 | JEMPERLI | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 16, 2025 | JAMP LATANOPROST | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 15, 2025 | GIVLAARI | Alnylam Netherlands B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| April 15, 2025 | LEDAGA | Recordati Rare Diseases Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 15, 2025 | APO-OXCARBAZEPINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 15, 2025 | SPC-MONTELUKAST | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 15, 2025 | BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP | Formative Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 15, 2025 | ZEULIDE DEPOT | Verity Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 15, 2025 | METADOL-D | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| April 15, 2025 | SPECTRAMAST DC | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 15, 2025 | EMEDOG | Domes Pharma | New Drug Submission (NDS) · Other |
| April 14, 2025 | POMBILITI | Amicus Therapeutics Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 14, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP | Baxter Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 14, 2025 | EYLEA; EYLEA HD | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 14, 2025 | TELMISARTAN HCTZ | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 14, 2025 | PMS-FAMPRIDINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 14, 2025 | ACT METHYLPHENIDATE ER | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 14, 2025 | APO-FAMPRIDINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 14, 2025 | ADVIL NIGHTTIME | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 14, 2025 | IBSRELA | Knight Therapeutics Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 14, 2025 | AG-DOXYCYCLINE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 14, 2025 | APO-FAMPRIDINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 11, 2025 | TEVA-TAMOXIFEN | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | APO-METHYLPHENIDATE ER | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 11, 2025 | AURO-DAPAGLIFLOZIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 11, 2025 | TEVA-ANASTROZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 11, 2025 | MED-ANASTROZOLE | Generic Medical Partners Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 11, 2025 | EUGIA-HYDROXYUREA | Eugia Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 11, 2025 | COMPLERA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | ROBAX PLATINUM | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | PRO-DICLOFENAC | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| April 11, 2025 | PRO-LANSOPRAZOLE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 11, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | COPAXONE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | LYRICA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | ALLEGRA 12 HOUR; ALLEGRA 24 HOUR; ALLEGRA HIVES | Sanofi Consumer Health Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | ALLEGRA-D | Sanofi Consumer Health Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2025 | NRA-PREGABALIN | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 10, 2025 | AMGEVITA | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 10, 2025 | EPCLUSA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 10, 2025 | LEVODEXA | Xediton Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 10, 2025 | OPFOLDA | Amicus Therapeutics Canada Inc. | New Drug Submission (NDS) · Other |
| April 10, 2025 | ACCEL-DULOXETINE | Accel Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 10, 2025 | NB-QUETIAPINE XR | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 10, 2025 | IMFINZI | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 9, 2025 | APO-DOMPERIDONE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 9, 2025 | APO-NORTRIPTYLINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 9, 2025 | PANTOPRAZOLE | Altamed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 9, 2025 | ELYXYB | Scilex Pharmaceuticals Inc. | New Drug Submission (NDS) · Other |
| April 9, 2025 | PREGABALIN | Altamed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 9, 2025 | TEVA-TADALAFIL | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 9, 2025 | TEVA-NITROFURANTOIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 8, 2025 | WEGOVY | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2025 | OMVYENCE | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| April 8, 2025 | KETOROLAC TROMETHAMINE INJECTION, USP | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 8, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 8, 2025 | FLUVIRAL | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2025 | DUREZOL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2025 | MVASI | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2025 | ADCETRIS | Seagen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2025 | TARO-DOMPERIDONE | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 8, 2025 | DULOXETINE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 8, 2025 | DIPENTUM | Searchlight Pharma Inc. | New Drug Submission (NDS) · Admin |
| April 8, 2025 | IMFINZI | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| April 8, 2025 | PMS-TERBINAFINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 7, 2025 | LINESSA 21; LINESSA 28 | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 7, 2025 | AG-AMOXI CLAV SUSPENSION | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 4, 2025 | ENHERTU | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 4, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 4, 2025 | APRI 21; APRI 28 | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 4, 2025 | JAMP KETOROLAC | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 4, 2025 | TARO-BUPROPION XL | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 4, 2025 | MINT-KETOROLAC | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 4, 2025 | SORIATANE | Allergan Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 4, 2025 | PROGLYCEM | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 4, 2025 | SANDOZ DONEPEZIL | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 4, 2025 | NDUVRA | Dermavant Sciences Gmbh | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 4, 2025 | TEVA-PREGABALIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 3, 2025 | KETOTIFEN OPHTHALMIC SOLUTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 3, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 3, 2025 | ACH-ANASTROZOLE | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 3, 2025 | VEKLURY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 3, 2025 | JAMP-AMOXICILLIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 2, 2025 | SANDOZ MORPHINE SR | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 2, 2025 | TARO-METHYLPHENIDATE ER | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 2, 2025 | NB-AMLODIPINE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 2, 2025 | APO-EZETIMIBE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 2, 2025 | ELIGARD | Tolmar International Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| April 2, 2025 | TD ADSORBED | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2025 | BENLYSTA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2025 | EUGIA-METHOTREXATE TABLETS | Eugia Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 1, 2025 | JAMP ATAZANAVIR | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 1, 2025 | AURO-ATOVAQUONE | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 1, 2025 | LITHMAX | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 1, 2025 | NAT-APIXABAN | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 1, 2025 | PREGABALIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 1, 2025 | REDDY-NILOTINIB | Dr Reddys Laboratories Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| April 1, 2025 | XOLAIR | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2025 | HALOETTE | Searchlight Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 31, 2025 | VEGZELMA | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 31, 2025 | NETSPOT | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 31, 2025 | AG-PERINDOPRIL / INDAPAMIDE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 31, 2025 | LUTATHERA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 31, 2025 | APO-SITAGLIPTIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 31, 2025 | UPLIZNA | Amgen Canada Inc | New Drug Submission (NDS) · Admin |
| March 31, 2025 | TERBINAFINE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 28, 2025 | PMS-METHOTREXATE INJECTION | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 28, 2025 | DOCETAXEL INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 28, 2025 | IBUPROFEN MUSCLE AND JOINT | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 28, 2025 | NAT-ANASTROZOLE | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 28, 2025 | MED-LATANOPROST | Generic Medical Partners Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 28, 2025 | M-CLINDAMYCIN | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 28, 2025 | SANDOZ VENLAFAXINE XR | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 28, 2025 | PLUVICTO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 28, 2025 | TORADOL | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 28, 2025 | NAT-BOSENTAN | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 28, 2025 | AG-ARIPIPRAZOLE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 28, 2025 | JAMP BILASTINE ORAL SOLUTION | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| March 27, 2025 | JAMP KETOTIFEN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 27, 2025 | TALTZ | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 27, 2025 | SILDENAFIL | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 27, 2025 | KOSELUGO | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| March 27, 2025 | CEFTIOFUR SODIUM FOR INJECTION | Bio Agri Mix Lp | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 27, 2025 | DUOTIC | Dechra Ltd | New Drug Submission (NDS) · Other |
| March 26, 2025 | ALTUVIIIO | Sanofi-Aventis Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 26, 2025 | LAMICTAL | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 26, 2025 | KETOROLAC TROMETHAMINE INJECTION, USP | Juno Pharmaceuticals Corp. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 26, 2025 | NRA-METFORMIN TABLETS | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 26, 2025 | NICARBAZIN 250 G | Bio Agri Mix Lp | New Drug Submission (NDS) · Other |
| March 25, 2025 | CARDIZEM CD | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2025 | ACH-TACROLIMUS | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 24, 2025 | TARO-LATANOPROST | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 24, 2025 | WEGOVY | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2025 | SANDOZ CLARITHROMYCIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 24, 2025 | ACT-HIB | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2025 | PENTACEL | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2025 | FILRA | JAMP Pharma Corporation | New Drug Submission (NDS) · Other |
| March 24, 2025 | M-TICAGRELOR | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 24, 2025 | RINVOQ | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2025 | AG-PREGABALIN | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 24, 2025 | IBRANCE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2025 | JAMP FEBUXOSTAT | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 21, 2025 | KAVIGALE | Astrazeneca Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 21, 2025 | PENTACEL | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 21, 2025 | OPSYNVI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 21, 2025 | METHOTREXATE SUBCUTANEOUS | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 21, 2025 | PMS-PALBOCICLIB | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 21, 2025 | MYLAN-MIRTAZAPINE | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 21, 2025 | MILEY 21; MILEY 28 | Ambicare Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 21, 2025 | RIVA RIVAROXABAN | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 20, 2025 | PAXLOVID | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 20, 2025 | IMBRUVICA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 20, 2025 | XFUSOR | Formative Pharma Inc. | New Drug Submission (NDS) · Other |
| March 20, 2025 | MYCAMINE | Sandoz Canada Inc. | New Drug Submission (NDS) · Admin |
| March 20, 2025 | NASAL SPRAY ALLERGY 24HR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 19, 2025 | IPG-ZOLMITRIPTAN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 19, 2025 | PLUVICTO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 19, 2025 | SEROQUEL XR | Cheplapharm Arzneimittel Gmbh | New Drug Submission (NDS) · Labelling Only |
| March 19, 2025 | KETOROLAC TROMETHAMINE INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 19, 2025 | ZEVTERA | Avir Pharma Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 19, 2025 | NORVIR | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 19, 2025 | KALETRA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 19, 2025 | OCTREOTIDE ACETATE OMEGA | Omega Laboratories Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 19, 2025 | BIO-CIPROFLOXACIN | Biomed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 19, 2025 | APO-ATOMOXETINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 19, 2025 | RIVAROXABAN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 18, 2025 | SEROQUEL | Cheplapharm Arzneimittel Gmbh | New Drug Submission (NDS) · Labelling Only |
| March 18, 2025 | VELSIPITY | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 18, 2025 | MIRTAZAPINE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 18, 2025 | HIZENTRA | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 18, 2025 | METADOL | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| March 18, 2025 | AG-ANASTROZOLE TABLETS | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 18, 2025 | JAMP ONDANSETRON ODT | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| March 18, 2025 | COATED DAILY LOW DOSE ASA 81 MG | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 18, 2025 | SUPRELORIN 4.7 MG IMPLANT | Virbac Ah, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 18, 2025 | AG-AMOXI CLAV | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 17, 2025 | APO-FLUTICASONE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 17, 2025 | XEOMIN | Merz Pharmaceuticals Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| March 17, 2025 | APO-ARIPIPRAZOLE DEPOT | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 17, 2025 | JAMP KETOROLAC | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 17, 2025 | BUPROPION HCL XL | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| March 15, 2025 | TIAZAC XC | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 14, 2025 | TAFINLAR | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 14, 2025 | ODEFSEY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 14, 2025 | FINACEA | Leo Pharma Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 14, 2025 | ZERBAXA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 13, 2025 | JAMP ROSUVASTATIN CALCIUM | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 13, 2025 | JAMP TICAGRELOR | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 13, 2025 | TEVA-ROSUVASTATIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 13, 2025 | SKYCLARYS | Biogen Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| March 13, 2025 | NB-SERTRALINE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 13, 2025 | HYQVIA | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| March 13, 2025 | ADVIL PEDIATRIC DROPS; ADVIL PEDIATRIC DROPS FEVER FROM COLDS OR FLU; CHILDREN'S ADVIL; CHILDREN'S ADVIL CHEWABLE TABLETS; CHILDREN'S ADVIL FEVER FROM COLDS OR FLU; JUNIOR STRENGTH ADVIL; JUNIOR STRENGTH ADVIL FEVER FROM COLDS OR FLU | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 13, 2025 | NRA-ZOLMITRIPTAN | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 13, 2025 | ZORYVE | Arcutis Canada, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 13, 2025 | MILBEGUARD DUO | Ceva Animal Health Inc | Abbreviated New Drug Submission (ANDS) · Other |
| March 13, 2025 | TEVA-ATAZANAVIR | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 12, 2025 | AKEEGA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 12, 2025 | MONTELUKAST | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 12, 2025 | JAMP KETOTIFEN OPHTHALMIC | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 12, 2025 | TEVA-LOSARTAN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 12, 2025 | RIVA-DORZOLAMIDE/TIMOLOL | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 12, 2025 | AA-MEDROXY | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 12, 2025 | JAMP SITAGLIPTIN HYDROCHLORIDE / METFORMIN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| March 12, 2025 | ACID CONTROLLER MAXIMUM STRENGTH | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 11, 2025 | COSENTYX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2025 | WEGOVY | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2025 | ALECENSARO | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2025 | TARO-PALBOCICLIB | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 11, 2025 | KALYDECO | Vertex Pharmaceuticals (Canada) Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2025 | GEMCITABINE INJECTION | Juno Pharmaceuticals Corp. | Abbreviated New Drug Submission (ANDS) · Other |
| March 10, 2025 | HYPERRHO S/D FULL DOSE | Grifols Therapeutics Llc | Supplement to a New Drug Submission (SNDS) · Other |
| March 10, 2025 | BOTOX | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 7, 2025 | REMDANTRY | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 7, 2025 | TAPAZOLE | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| March 7, 2025 | ZYNLONTA | Swedish Orphan Biovitrum Ab (Publ) | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 7, 2025 | NRA-FINASTERIDE | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 7, 2025 | ZOLGENSMA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 7, 2025 | VOSEVI | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 7, 2025 | TELMISARTAN | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 7, 2025 | LUPIN-PROPRANOLOL LA | Lupin Pharma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 7, 2025 | PMS-ANASTROZOLE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 7, 2025 | MYLAN-HYDROXYUREA | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 7, 2025 | PMS-CETIRIZINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 7, 2025 | KETOROLAC TROMETHAMINE INJECTION USP | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 7, 2025 | TEVA-MEDROXYPROGESTERONE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 7, 2025 | APO-VORTIOXETINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 7, 2025 | ANALGESIC AND MUSCLE RELAXANT | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| March 7, 2025 | CYCLOSPORINE | Edenbridge Pharmaceuticals, Llc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 6, 2025 | HEMLIBRA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 6, 2025 | LUTATHERA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 6, 2025 | CEFTRIAXONE SODIUM FOR INJECTION BP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 6, 2025 | MAXIMUM STRENGTH PEPCID AC; PEPCID AC | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 6, 2025 | NAPROXEN CAPSULES 200 MG | Catalent Ontario Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 6, 2025 | CEFAZOLIN IN DEXTROSE INJECTION, USP | Baxter Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 6, 2025 | PLUVICTO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 6, 2025 | LAZCLUZE | Janssen Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 5, 2025 | ACARIZAX | Alk-Abello Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 5, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 5, 2025 | REBYOTA | Ferring Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 5, 2025 | SANDOMIGRAN DS | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| March 5, 2025 | PMS-BETAHISTINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 5, 2025 | NALCROM | Lupin Pharma Canada Limited | New Drug Submission (NDS) · Admin |
| March 5, 2025 | WOMEN'S GLN-MINOXIDIL | Glenmark Pharmaceuticals Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 5, 2025 | NB-CITALOPRAM | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 5, 2025 | JAMP ALMOTRIPTAN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| March 4, 2025 | CODEINE CONTIN | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | BOTOX COSMETIC | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | DOCETAXEL INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 4, 2025 | LUMAKRAS | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | DECAPEPTYL | Ferring Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | GEN-CLOZAPINE | Mylan Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | OLIMEL 4.4%; OLIMEL 5.7%; OLIMEL 7.6% | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | OLIMEL 3.3% E; OLIMEL 4.4% E; OLIMEL 5.7% E; OLIMEL 7.6% E; PERIOLIMEL 2.5% E | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2025 | SIMPLERA | Vetoquinol N A Inc | Abbreviated New Drug Submission (ANDS) · Other |
| March 3, 2025 | PLUVICTO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 3, 2025 | CABAZITAXEL FOR INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 3, 2025 | EYLEA HD | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 3, 2025 | AG-FLUCONAZOLE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| March 3, 2025 | APO-DAPAGLIFLOZIN-METFORMIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 3, 2025 | MYLAN-AZELASTINE/FLUTICASONE | Mylan Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Admin |
| February 28, 2025 | APO-HYDROXYUREA | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 28, 2025 | SANDOZ TOFACITINIB | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 28, 2025 | MIRVALA 21; MIRVALA 28 | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 28, 2025 | APO-GLICLAZIDE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 28, 2025 | TEVA-NABILONE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 28, 2025 | MYTOLAC | Advanz Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 28, 2025 | STEQEYMA; STEQEYMA I.V. | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 28, 2025 | TIAZAC | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 28, 2025 | AG-DUTASTERIDE | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 28, 2025 | QALSODY | Biogen Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| February 28, 2025 | NRA-EZETIMIBE TABLETS | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 28, 2025 | APO-IMIQUIMOD | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 27, 2025 | INFANRIX-IPV/HIB | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2025 | ENTROPHEN 325MG CAPLETS; ENTROPHEN 325MG TABLETS; ENTROPHEN CHEWABLE | Pendopharm Division Of Pharmascience Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2025 | POTELIGEO | Kyowa Kirin, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2025 | NRA-ROSUVASTATIN TABLETS | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 27, 2025 | GALANTAMINE ER | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 27, 2025 | PMS-DOXYCYCLINE | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| February 27, 2025 | OXY.IR | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2025 | OXYNEO | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2025 | DAPTOMYCIN FOR INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 27, 2025 | TARO-ROPINIROLE | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 27, 2025 | SILENOR | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| February 27, 2025 | NB-PERINDOPRIL | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 27, 2025 | DESVENLAFAXINE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 27, 2025 | CLOPROSTENOL INJECTIONS | Alivira Animal Health Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 26, 2025 | RINVOQ | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| February 26, 2025 | ALAMYCIN 200 LA | Norbrook Laboratories Ltd. | Supplement to a New Drug Submission (SNDS) · Admin |
| February 25, 2025 | AURO-IRBESARTAN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 25, 2025 | ALEMBIC-TELMISARTAN/HCTZ | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 25, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 25, 2025 | ENTROPHEN | Pendopharm Division Of Pharmascience Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 25, 2025 | CAYSTON | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 25, 2025 | ODAN BUPROPION SR | Odan Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 25, 2025 | BIO-PAROXETINE | Biomed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 25, 2025 | ZENHALE | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 25, 2025 | VENTOLIN RESPIRATOR SOLUTION | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 25, 2025 | AURO-AZILSARTAN MEDOXOMIL | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 25, 2025 | BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP | Omega Laboratories Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 24, 2025 | SUBLOCADE | Indivior Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 24, 2025 | ZOMIG RAPIMELT | Xediton Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 24, 2025 | RIVA-ROSUVASTATIN | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 24, 2025 | MAR-KETOROLAC | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 24, 2025 | ICLUSIG | Takeda Pharmaceuticals U.S.A., Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 21, 2025 | ODAN BUPROPION SR | Odan Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 21, 2025 | APO-CEFUROXIME | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 21, 2025 | PMS-ZOPICLONE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 21, 2025 | JAMP ZOPICLONE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 21, 2025 | BIO-ROSUVASTATIN | Biomed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 21, 2025 | PLAQUENIL | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 21, 2025 | IBUPROFEN+METHOCARBAMOL CAPLETS | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 21, 2025 | FREYA 21; FREYA 28 | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 21, 2025 | JAMP ONDANSETRON ODF | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | ACH-TELMISARTAN HCTZ | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | MINT-LATANOPROST | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | APO-ROSUVASTATIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | SANDOZ TELMISARTAN HCT | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | M-DORZOLAMIDE-TIMOLOL | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 20, 2025 | APO-CLINDAMYCIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2025 | INREBIC | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| February 20, 2025 | NB-ATORVASTATIN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 19, 2025 | S&S SANITIZER | Ecolab Co. | Supplement to a New Drug Submission (SNDS) · Other |
| February 19, 2025 | PMS-BOSENTAN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 19, 2025 | BACKUP PLAN ONESTEP | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 19, 2025 | TRIDURAL | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| February 19, 2025 | EXELERATE CSD 15 | Ecolab Co. | Supplement to a New Drug Submission (SNDS) · Other |
| February 19, 2025 | CLEANING SANITIZER AND DISINFECTANT RTU | Ecolab Co. | Supplement to a New Drug Submission (SNDS) · Other |
| February 19, 2025 | APO-ZOPICLONE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 18, 2025 | APO-QUETIAPINE FUMARATE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 18, 2025 | AREPANRIX H5N1 | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Other |
| February 18, 2025 | CEFUROXIME FOR INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 18, 2025 | AURO-EZETIMIBE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 18, 2025 | JAMP-MEMANTINE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 18, 2025 | PRO-FLUCONAZOLE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 18, 2025 | ALAMYCIN 300 LA | Norbrook Laboratories Ltd. | Supplement to a New Drug Submission (SNDS) · Admin |
| February 17, 2025 | RABAVERT | Bavarian Nordic As | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | WINREVAIR | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | ANTHRASIL | Emergent Biosolutions Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | ACTIVELLE; ACTIVELLE LD | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | RECOTHROM | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | APO-GABAPENTIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 17, 2025 | PROVERA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | TASIGNA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2025 | JAMP DAPAGLIFLOZIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 14, 2025 | ACT ZOPICLONE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 14, 2025 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 14, 2025 | TEVA-ZOPICLONE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 14, 2025 | FIROLIX CHEWABLE TABLETS | Felix Pharmaceuticals Pvt. Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| February 14, 2025 | LOCACORTEN VIOFORM | Endo Operations Ltd. | New Drug Submission (NDS) · Labelling Only |
| February 14, 2025 | APO-LEVOFLOXACIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 14, 2025 | ITOVEBI | Hoffmann-La Roche Limited | New Drug Submission (NDS) · Priority-NAS |
| February 14, 2025 | WAKIX | Endo Ventures Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| February 14, 2025 | NB-ROSUVASTATIN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 14, 2025 | ICATIBANT INJECTION | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 13, 2025 | VISTITAN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 13, 2025 | FLUZONE; FLUZONE HIGH-DOSE | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 13, 2025 | JAMP FINASTERIDE TABLETS | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| February 13, 2025 | ISOFLURANE USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 13, 2025 | FAMVIR | Searchlight Pharma Inc. | New Drug Submission (NDS) · Admin |
| February 13, 2025 | FLUOXETINE | Sivem Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| February 13, 2025 | TRANEXAMIC ACID INJECTION BP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 13, 2025 | APO-ESLICARBAZEPINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 13, 2025 | NEXIUM 24HR | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2025 | MAR-PERINDOPRIL | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 12, 2025 | IBUPROFEN CAPSULES 200 MG | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 12, 2025 | KLOXXADO | Hikma Canada Limited | New Drug Submission (NDS) · Other |
| February 12, 2025 | ARAVA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2025 | RABEPRAZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 11, 2025 | MIFEGYMISO | Linepharma International Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2025 | APO-KETOROLAC | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2025 | PRAMIPEXOLE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 11, 2025 | TARO-BOSENTAN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 11, 2025 | NEXTSTELLIS | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2025 | APO-APIXABAN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 11, 2025 | RALIVIA | Bausch Health, Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2025 | XATRAL | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2025 | LEQVIO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 10, 2025 | RABAVERT | Bavarian Nordic As | Supplement to a New Drug Submission (SNDS) · Other |
| February 10, 2025 | REMSIMA | Celltrion Healthcare Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| February 10, 2025 | COMIRNATY OMICRON XBB.1.5 | Biontech Manufacturing Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| February 10, 2025 | CAELYX | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| February 10, 2025 | JAMP SILDENAFIL TABLETS | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 7, 2025 | MELPHALAN FOR INJECTION | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 7, 2025 | AG-EZETIMIBE | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 7, 2025 | JAMP-EZETIMIBE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 7, 2025 | DICLOFENAC DIETHYLAMINE GEL EXTRA STRENGTH | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 7, 2025 | TARO-TOFACITINIB | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 7, 2025 | ZOLMITRIPTAN; ZOLMITRIPTAN ODT | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 7, 2025 | JAMP-GABAPENTIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 7, 2025 | ONDANSETRON ODT | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 7, 2025 | NB-RISPERIDONE | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 7, 2025 | METHOTREXATE SODIUM INJECTION | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 6, 2025 | TEVA-VORICONAZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 6, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 6, 2025 | ZYNYZ | Incyte Corporation | New Drug Submission (NDS) · New Active Substance (NAS) |
| February 6, 2025 | AG-RIVAROXABAN | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 6, 2025 | BMD-ATORVASTATIN | Biomed Pharma | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| February 6, 2025 | AURO-NITROFURANTOIN BID | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 5, 2025 | TELMISARTAN HCTZ | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| February 5, 2025 | NEXIUM 24HR | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| February 5, 2025 | BALVERSA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 5, 2025 | BICNU | Marcan Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 5, 2025 | AG-SILDENAFIL TABLETS | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 5, 2025 | ENGEMYCIN DD | Intervet Canada Corp | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 4, 2025 | BIKTARVY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 4, 2025 | DONEPEZIL | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 4, 2025 | DOMPERIDONE | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 3, 2025 | TEVA-ELTROMBOPAG | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 3, 2025 | ZOLMITRIPTAN; ZOLMITRIPTAN ODT | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 3, 2025 | TEVA-PAROXETINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 3, 2025 | ADDERALL XR | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | IMODIUM LIQUI-GELS; IMODIUM QUICK DISSOLVE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | DIARRHEA RELIEF | Vita Health Products Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | NB-RIVAROXABAN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 31, 2025 | PENTHROX | Endo Operations Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | VASERETIC | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | VASOTEC | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | OXLUMO | Alnylam Netherlands B.V. | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | ATGAM | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2025 | APO-TOFACITINIB | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 31, 2025 | SARCLISA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 30, 2025 | IMVAMUNE | Bavarian Nordic As | Supplement to a New Drug Submission (SNDS) · Other |
| January 30, 2025 | ZYPREXA; ZYPREXA INTRAMUSCULAR; ZYPREXA ZYDIS | Cheplapharm Registration Gmbh | New Drug Submission (NDS) · Labelling Only |
| January 30, 2025 | SOLU-MEDROL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 30, 2025 | EZETIMIBE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 30, 2025 | TALZENNA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 30, 2025 | REMICADE | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 30, 2025 | PREGABALIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 30, 2025 | JORNAY PM | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| January 30, 2025 | DAYVIGO | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2025 | VOLTAREN EMULGEL; VOLTAREN EMULGEL ACTIVE; VOLTAREN EMULGEL BACK & MUSCLE PAIN; VOLTAREN EMULGEL JOINT PAIN REGULAR STRENGTH | Haleon Canada ULC | New Drug Submission (NDS) · Labelling Only |
| January 29, 2025 | NAPROXEN MENSTRUAL PAIN RELIEF | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 29, 2025 | MYFORTIC | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2025 | QUVIVIQ | Idorsia Pharmaceuticals Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2025 | MONOFERRIC | Pharmacosmos A | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2025 | OZEMPIC | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2025 | SEPTANEST N; SEPTANEST SP | Septodont | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2025 | PRO-METFORMIN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| January 29, 2025 | LEGEND MULTI DOSE | Boehringer Ingelheim Animal Health Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 28, 2025 | PEMETREXED DISODIUM FOR INJECTION | Hikma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| January 28, 2025 | RETROVIR (AZT) | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 28, 2025 | SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USP | Eugia Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 27, 2025 | KADCYLA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 27, 2025 | DOPTELET | Swedish Orphan Biovitrum Ab (Publ) | Supplement to a New Drug Submission (SNDS) · Other |
| January 27, 2025 | M-AMOXI CLAV | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 27, 2025 | FLUMIST | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 27, 2025 | MEDROL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 24, 2025 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 24, 2025 | AURO-BOSENTAN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 24, 2025 | DEPO-MEDROL WITH LIDOCAINE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 24, 2025 | GEN-CLOZAPINE | Mylan Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 24, 2025 | BIO-CETIRIZINE | Biomed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 24, 2025 | AURO-RISEDRONATE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 24, 2025 | NATCO-ESCITALOPRAM | Natco Pharma (Canada) Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 24, 2025 | DOCETAXEL INJECTION | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 24, 2025 | PMS-PREDNISOLONE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 24, 2025 | ROSUVASTATIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 23, 2025 | CETIRIZINE | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 23, 2025 | VIVACAINE | Septodont | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 23, 2025 | XYREM | Jazz Pharmaceuticals Ireland Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 23, 2025 | JAMP DOXYCYCLINE TABLETS | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| January 23, 2025 | JAMP CLINDAMYCIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 23, 2025 | FINASTERIDE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 23, 2025 | APO-TICAGRELOR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 23, 2025 | DESVENLAFAXINE | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 23, 2025 | CALCITONIN SALMON INJECTION USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 23, 2025 | JAMP ATAZANAVIR | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 23, 2025 | APO-DASATINIB | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 23, 2025 | NAQUASONE | Intervet Canada Corp | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | AERIUS KIDS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | TRUVADA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | COMBOGESIC IV | Aft Pharmaceuticals (Can) Limited | New Drug Submission (NDS) · Admin |
| January 22, 2025 | NINLARO | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | RYBELSUS | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | NB-PREGABALIN | NB Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 22, 2025 | FORXIGA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | XIGDUO | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2025 | APO-DEXLANSOPRAZOLE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 21, 2025 | CARVYKTI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 21, 2025 | PMS-RUPATADINE | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 21, 2025 | APO-RUPATADINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 21, 2025 | IBUPROFEN MINI LIQUID CAPSULES | Juno Otc Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 20, 2025 | PROQUAD | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 20, 2025 | EYLEA HD | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 20, 2025 | TOMVI | Sterimax Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 20, 2025 | TARO-MELPHALAN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 20, 2025 | LEVULAN KERASTICK | Sun Pharmaceutical Industries Limited | New Drug Submission (NDS) · Admin |
| January 17, 2025 | LITFULO | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2025 | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, BP | Juno Pharmaceuticals Corp. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 17, 2025 | IBUPROFEN MINI LIQUID CAPSULES | Juno Otc Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 17, 2025 | ENHERTU | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2025 | NRA-FLUCONAZOLE-150 | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 17, 2025 | IMFINZI | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2025 | JAMP DORZOLAMIDE-TIMOLOL | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 17, 2025 | ADVIL 12 HOUR; ADVIL CAPLETS; ADVIL EXTRA STRENGTH CAPLETS; ADVIL MUSCLE AND JOINT; ADVIL TABLETS | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2025 | BAXDELA | Xediton Pharmaceuticals Inc. | New Drug Submission (NDS) · Priority-NAS |
| January 17, 2025 | ABILIFY ASIMTUFII; ABILIFY MAINTENA | Otsuka Pharmaceutical Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2025 | TEVA-DOXAZOSIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 16, 2025 | CEFTRIAXONE INJECTION, USP | Baxter Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 16, 2025 | MINT-SILDENAFIL | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 16, 2025 | APO-METHYLPHENIDATE SR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 15, 2025 | HADLIMA; HADLIMA PUSHTOUCH | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2025 | OZEMPIC | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2025 | MINT-ZOLMITRIPTAN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 15, 2025 | NPLATE | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2025 | ARIPIPRAZOLE ORAL SOLUTION | Orimed Pharma Inc. | New Drug Submission (NDS) · Other |
| January 14, 2025 | RIVAROXABAN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 14, 2025 | ULTRAVIST 300; ULTRAVIST 370 | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 14, 2025 | APO-NILOTINIB | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2025 | LISINOPRIL TABLETS | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 14, 2025 | DEXTROAMPHETAMINE | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 14, 2025 | AURO-VARENICLINE | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 13, 2025 | RYBREVANT | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 13, 2025 | JAMP AMOXI CLAV SUSPENSION | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 10, 2025 | BAT | Emergent Biosolutions Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | ELIQUIS | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | KINERET | Swedish Orphan Biovitrum Ab (Publ) | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | TEVA-LATANOPROST-TIMOLOL | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2025 | ORGALUTRAN | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | AURO-DIGOXIN | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 10, 2025 | RETEVMO | Loxo Oncology Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | PYLERA | Laboratoires Juvise Pharmaceuticals | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | ADVIL COLD & SINUS PLUS; ADVIL COLD AND SINUS NIGHTTIME; ADVIL COLD, SINUS & FLU EXTRA STRENGTH; CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | LUMAKRAS | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2025 | ARSENIC TRIOXIDE FOR INJECTION | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 9, 2025 | KERENDIA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | M-DILTIAZEM CD | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 9, 2025 | HEPAGAM B | Ki Biopharma Llc | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | KAMRAB | Kamada Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | ZIEXTENZO | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | TYSABRI | Biogen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | TECENTRIQ; TECENTRIQ SC | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | REMSIMA | Celltrion Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2025 | GABAPENTIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 8, 2025 | MAR-PREGABALIN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 8, 2025 | APO-FLUOXETINE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| January 8, 2025 | TARO-DOXORUBICIN LIPOSOMAL | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 8, 2025 | ALENDRONATE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 8, 2025 | PMS-VALPROIC ACID; PMS-VALPROIC ACID E.C. | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 8, 2025 | DIVALPROEX | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 8, 2025 | PMS-METHOTREXATE | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 7, 2025 | ZOLMITRIPTAN | Jubilant Generics Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 7, 2025 | VORICONAZOLE FOR INJECTION | Eugia Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 7, 2025 | APO-FESOTERODINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 7, 2025 | AURO-AMOXICLAV | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 7, 2025 | APO-IBUPROFEN; APO-IBUPROFEN CAPLET | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 7, 2025 | BACLOFEN INJECTION | Hikma Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 6, 2025 | TVA-LEVETIRACETAM | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| January 6, 2025 | FABHALTA | Novartis Pharmaceuticals Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| January 6, 2025 | VALPROIC ACID; VALPROIC ACID ORAL SOLUTION | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 6, 2025 | ADVAIR | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 3, 2025 | APO-DEXTROAMPHETAMINE SR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 3, 2025 | RIVA-SILDENAFIL | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 3, 2025 | TRUQAP | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 2, 2025 | TARO-DAPAGLIFLOZIN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 2, 2025 | TARO-DAPAGLIFLOZIN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 2, 2025 | TEVA-ZOLMITRIPTAN; TEVA-ZOLMITRIPTAN OD | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 2, 2025 | GARDASIL 9 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 2, 2025 | GARDASIL 9 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |