Notices of Compliance, 2019
1,371 notices issued in 2019, newest first.
| Date | Products | Company | Submission |
|---|---|---|---|
| December 31, 2019 | ALYSENA 21; ALYSENA 28 | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 31, 2019 | M-ESCITALOPRAM | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| December 31, 2019 | BORTEZOMIB FOR INJECTION | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 30, 2019 | VASCEPA | Hls Therapeutics Inc | New Drug Submission (NDS) · Priority-NAS |
| December 30, 2019 | DEMYLOCAN | Pendopharm Division Of Pharmascience Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 30, 2019 | APO-TRAVOPROST-TIMOLOL PQ | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 30, 2019 | PRO-GABAPENTIN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| December 27, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 27, 2019 | GRASTOFIL | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 27, 2019 | LAPELGA | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 23, 2019 | MUSCLE AND BACK PAIN PLATINUM RELIEF | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 23, 2019 | SANDOZ CLOBETASOL | Sandoz Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| December 23, 2019 | TEVA-METHYLPHENIDATE ER-C | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 23, 2019 | CELECOXIB | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 23, 2019 | AERMONY RESPICLICK | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 23, 2019 | XOSPATA | Astellas Pharma Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| December 23, 2019 | RINVOQ | AbbVie Corporation | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 20, 2019 | APO-CETIRIZINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 20, 2019 | ALEVE BACK AND BODY PAIN | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 20, 2019 | IPG-CETIRIZINE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 20, 2019 | OLIMEL 3.3% E; OLIMEL 4.4%; OLIMEL 4.4% E; OLIMEL 5.7%; OLIMEL 5.7% E; OLIMEL 7.6%; OLIMEL 7.6% E; PERIOLIMEL 2.5% E | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| December 20, 2019 | 0.4% LIDOCAINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION | Baxter Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 20, 2019 | ADVIL ARTHRITIS PAIN; ADVIL EXTRA STRENGTH LIQUI-GELS; ADVIL LIQUI-GELS | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 19, 2019 | JAMP IMATINIB | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| December 19, 2019 | VEPESID | Cheplapharm Arzneimittel Gmbh | New Drug Submission (NDS) · Admin |
| December 19, 2019 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| December 19, 2019 | LIORESAL INTRATHECAL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 19, 2019 | LOVENOX; LOVENOX HP | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 19, 2019 | BLINCYTO | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 18, 2019 | MILRINONE LACTATE INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 18, 2019 | ADREVIEW | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 18, 2019 | PMS-ATORVASTATIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 17, 2019 | TARO-BUPROPION XL | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 17, 2019 | SALAZOPYRIN; SALAZOPYRIN EN-TABS | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 17, 2019 | ACT BUPRENORPHINE/NALOXONE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| December 17, 2019 | CABAZITAXEL FOR INJECTION | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 17, 2019 | PRISTIQ | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2019 | NAT-PREGABALIN | Natco Pharma (Canada) Inc | Abbreviated New Drug Submission (ANDS) · Other |
| December 17, 2019 | INDIUM (111IN) OXINE SOLUTION | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 16, 2019 | ZEMAIRA | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 16, 2019 | IBUPROFEN | JAMP Pharma Corporation | New Drug Submission (NDS) · Labelling Only |
| December 16, 2019 | BORTEZOMIB FOR INJECTION | Mda Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 13, 2019 | RETIN-A | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| December 13, 2019 | TARO-ATORVASTATIN | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 13, 2019 | FUNGIZONE | Cheplapharm Arzneimittel Gmbh | New Drug Submission (NDS) · Admin |
| December 13, 2019 | LORAZEPAM INJECTION USP | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 13, 2019 | SOLIRIS | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| December 13, 2019 | ZYTRAM XL | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| December 13, 2019 | PANTOPRAZOLE | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| December 13, 2019 | CUPRIMINE | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| December 13, 2019 | APO-LEVOFLOXACIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 13, 2019 | MAR-FLUCONAZOLE-150 | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 13, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2019 | SATIVEX | Gw Pharma Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 12, 2019 | ERLEADA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Priority |
| December 11, 2019 | BUSCOPAN | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 11, 2019 | ACT DEXTROAMPHETAMINE SR | Teva Canada Limited | New Drug Submission (NDS) · Admin |
| December 11, 2019 | TERBINAFINE | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| December 11, 2019 | TARO-SOLIFENACIN | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 11, 2019 | DOTAREM | Guerbet | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2019 | PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI | Pharmascience Inc. | New Drug Submission (NDS) · Labelling Only |
| December 10, 2019 | DULOXETINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 10, 2019 | SANDOZ OLMESARTAN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 10, 2019 | LOVENOX | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2019 | OBIZUR | Shire Pharma Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2019 | XEMBIFY | Grifols Therapeutics Llc | New Drug Submission (NDS) · Other |
| December 9, 2019 | RELISTOR | Salix Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 9, 2019 | SANDOSTATIN LAR | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 9, 2019 | JAMP PRUCALOPRIDE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| December 9, 2019 | APO-PRUCALOPRIDE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 6, 2019 | ACT QUETIAPINE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| December 6, 2019 | HAVRIX 1440; HAVRIX 720 JR | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 6, 2019 | JUBLIA | Valeant Canada Lp Valeant Canada S.E.C. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 6, 2019 | PERIOGARD | Colgate-Palmolive Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 6, 2019 | TEVA-EVEROLIMUS | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 6, 2019 | JAMP CEPHALEXIN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| December 6, 2019 | PIFELTRO | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 6, 2019 | INSPIOLTO RESPIMAT | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| December 6, 2019 | TEVA-TOPIRAMATE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 6, 2019 | TEVA-EVEROLIMUS | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| December 6, 2019 | LANTUS | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| December 5, 2019 | FRAGMIN | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| December 5, 2019 | EVICEL | Omrix Biopharmaceuticals Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| December 4, 2019 | TEVA-EZETIMIBE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 4, 2019 | CLADRIBINE INJECTION | Generic Medical Partners Inc | Abbreviated New Drug Submission (ANDS) · Other |
| December 4, 2019 | VENCLEXTA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| December 4, 2019 | DEFITELIO | Jazz Pharmaceuticals Ireland Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 4, 2019 | PACLITAXEL INJECTION USP | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 3, 2019 | CARIPUL | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 3, 2019 | ACYCLOVIR SODIUM INJECTION | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 2, 2019 | ACT ROPINIROLE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| December 2, 2019 | CELECOXIB | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 2, 2019 | PRIVA-CELECOXIB | Pharmapar Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| December 2, 2019 | AG-METFORMIN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 2, 2019 | APO-CLINDAMYCIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 2, 2019 | TEVA-CARVEDILOL | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| December 2, 2019 | CEFAZOLIN FOR INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 29, 2019 | METVIX | Galderma Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 29, 2019 | NIX DERMAL CREAM | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 29, 2019 | JAMP-CHOLESTYRAMINE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2019 | CALQUENCE | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 28, 2019 | APO-DASATINIB | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 28, 2019 | APO-DASATINIB | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 28, 2019 | MYLOTARG | Pfizer Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| November 27, 2019 | SANDOZ TAMSULOSIN CR | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 27, 2019 | PHARIXIA ALCOHOL FREE | Pendopharm Division Of Pharmascience Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 27, 2019 | IMMITICIDE | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| November 27, 2019 | EQVALAN GOLD | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| November 27, 2019 | EQVALAN | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| November 27, 2019 | GASTROGARD | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| November 27, 2019 | TREMFYA ONE-PRESS; TREMFYA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2019 | APIDRA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 26, 2019 | AMOXIL | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2019 | BMD 110 G | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 25, 2019 | MAR-CELECOXIB | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 25, 2019 | PMS-TADALAFIL | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 25, 2019 | APRESOLINE | Sterimax Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 25, 2019 | PRIVA-RANITIDINE | Pharmapar Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| November 25, 2019 | APRI 21; APRI 28 | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| November 25, 2019 | AKLIEF | Galderma Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| November 25, 2019 | KADCYLA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Priority |
| November 25, 2019 | MVASI | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 22, 2019 | IBUPROFEN LIQUID GELS | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| November 22, 2019 | OFEV | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Priority |
| November 22, 2019 | RENFLEXIS | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| November 22, 2019 | REVATIO | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 22, 2019 | ADCETRIS | Seattle Genetics Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| November 22, 2019 | ADMELOG | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 22, 2019 | FLUCELVAX QUAD | Seqirus Uk Limited | New Drug Submission (NDS) · Other |
| November 22, 2019 | ACT CABERGOLINE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| November 22, 2019 | SINCALIDE FOR INJECTION | Avir Pharma Inc | Abbreviated New Drug Submission (ANDS) · Other |
| November 22, 2019 | XIIDRA | Novartis Pharmaceuticals Canada Inc. | New Drug Submission (NDS) · Admin |
| November 22, 2019 | PROCYTOX | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 21, 2019 | ADVIL COLD, COUGH & FLU NIGHTTIME | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 21, 2019 | SHINGRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 21, 2019 | TEVA-LIOTHYRONINE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| November 21, 2019 | MYLAN-ATORVASTATIN | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 21, 2019 | ADVIL COLD & SINUS PLUS; ADVIL COLD, SINUS & FLU EXTRA STRENGTH; CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 21, 2019 | EXPERIOR 10 | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Admin |
| November 21, 2019 | OMEPRAZOLE | Laboratoire Riva Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 21, 2019 | NUCALA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 21, 2019 | ELOCTATE | Bioverativ Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 20, 2019 | TARO-FLUCONAZOLE | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 20, 2019 | BUPIVACAINE INJECTION BP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 20, 2019 | TARO-BUDESONIDE | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| November 19, 2019 | EMLA PATCH | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 19, 2019 | TOBI PODHALER | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 19, 2019 | LONSURF | Taiho Pharma Canada, Inc. | Supplement to a New Drug Submission (SNDS) · Priority |
| November 18, 2019 | TAPAZOLE | Paladin Labs Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 18, 2019 | PMS-AMANTADINE HYDROCHLORIDE CAPSULES; PMS-AMANTADINE HYDROCHLORIDE SYRUP | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| November 18, 2019 | PRIVA-OMEPRAZOLE | Pharmapar Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 18, 2019 | NRA-CLINDAMYCIN | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 18, 2019 | SANDOZ BISOPROLOL TABLETS | Sandoz Canada Inc. | New Drug Submission (NDS) · Other |
| November 15, 2019 | EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES; IBUPROFEN LIQUID GEL CAPSULES | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 15, 2019 | ALLEGRA 12 HOUR; ALLEGRA 24 HOUR | Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc | New Drug Submission (NDS) · Admin |
| November 15, 2019 | FETZIMA | Allergan Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 15, 2019 | RIVA LEUCOVORIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 15, 2019 | REDDY-ATORVASTATIN | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 15, 2019 | ZONOVATE | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 14, 2019 | MYLAN-RIZATRIPTAN ODT | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 14, 2019 | AZACITIDINE FOR INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 14, 2019 | APO-DULOXETINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 14, 2019 | MAR-ACARBOSE | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 13, 2019 | GALLI EO | Ire Elit S.A. | New Drug Submission (NDS) · New Active Substance (NAS) |
| November 13, 2019 | SYNFLORIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 13, 2019 | CIMZIA | Ucb Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 12, 2019 | APO-COLESEVELAM | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 12, 2019 | TARO-PHENYTOIN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 12, 2019 | HALOPERIDOL INJECTION | Neo Health Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 12, 2019 | CLOMICALM | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 8, 2019 | ADVIL COLD AND SINUS NIGHTTIME | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 8, 2019 | ADVIL 12 HOUR; ADVIL CAPLETS; ADVIL EXTRA STRENGTH CAPLETS; ADVIL MUSCLE AND JOINT; ADVIL TABLETS | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 8, 2019 | TRAJENTA | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| November 8, 2019 | ACARBOSE TABLETS | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Other |
| November 8, 2019 | KAMRAB | Kamada Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 8, 2019 | JAMP FLECAINIDE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| November 8, 2019 | CABOMETYX | Ipsen Biopharmaceuticals Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 8, 2019 | VORICONAZOLE FOR INJECTION | Fresenius Kabi Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| November 8, 2019 | LINESSA 21; LINESSA 28 | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 8, 2019 | ACH-CAPECITABINE | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 7, 2019 | ADVIL PEDIATRIC DROPS; ADVIL PEDIATRIC DROPS FEVER FROM COLDS OR FLU; CHILDREN'S ADVIL; CHILDREN'S ADVIL FEVER FROM COLDS OR FLU; JUNIOR STRENGTH ADVIL; JUNIOR STRENGTH ADVIL FEVER FROM COLDS OR FLU | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 7, 2019 | ZANTAC; ZANTAC MAXIMUM STRENGTH NON-PRESCRIPTION | Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 7, 2019 | LOPERACAP | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| November 7, 2019 | ADVIL NIGHTTIME | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 7, 2019 | CLINDAMYCIN INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 7, 2019 | IBRANCE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 7, 2019 | INTERCEPTOR PLUS | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT TE-H IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT TE-200 IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT TE-G IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT TE-100 IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT E-C IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT E-H IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT E-S IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 7, 2019 | COMPONENT TE-S IMPLANTS WITH TYLAN | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| November 6, 2019 | BAVENCIO | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| November 6, 2019 | VIAGRA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 6, 2019 | RABEPRAZOLE EC | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 6, 2019 | IMBRUVICA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 6, 2019 | JORVEZA | Avir Pharma Inc | New Drug Submission (NDS) · Priority |
| November 5, 2019 | ASN-HYDRALAZINE | Ascend Laboratories Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| November 5, 2019 | SANDOZ FENOFIBRATE S | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 5, 2019 | SANDOZ TRAMADOL | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 5, 2019 | APO-LAMIVUDINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 5, 2019 | SANDOZ ROSUVASTATIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| November 4, 2019 | JAMP ELETRIPTAN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| November 1, 2019 | INTRAROSA | Endoceutics Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| November 1, 2019 | PRO-FLUCONAZOLE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 1, 2019 | CLOPIDOGREL | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 1, 2019 | SOLIFENACIN SUCCINATE TABLETS | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| November 1, 2019 | LINEZOLID TABLETS | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| November 1, 2019 | BEZALIP SR | Allergan Inc | New Drug Submission (NDS) · Admin |
| November 1, 2019 | RAPAMUNE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| November 1, 2019 | BAR-BUPRENORPHINE | Bard Pharmaceuticals (1990) Inc | New Drug Submission (NDS) · Labelling Only |
| November 1, 2019 | MULTIHANCE | Bracco Imaging Canada | Supplement to a New Drug Submission (SNDS) · Other |
| November 1, 2019 | NIMENRIX | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| November 1, 2019 | LINCOMIX 100 | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2019 | ADVIL COLD & FLU | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 31, 2019 | AURO-PROGESTERONE | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 31, 2019 | IBRANCE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 31, 2019 | LORATADINE SOFT GELATIN CAPSULES | Catalent Ontario Limited | New Drug Submission (NDS) · Other |
| October 30, 2019 | CYTOGAM | Saol Therapeutics Research Limited | New Drug Submission (NDS) · Admin |
| October 30, 2019 | AURO-DULOXETINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 30, 2019 | SEGLUROMET | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 30, 2019 | KINEVAC | Bracco Imaging Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 30, 2019 | ADAXIO SHAMPOO | Ceva Animal Health Inc | New Drug Submission (NDS) · Other |
| October 29, 2019 | JARDIANCE | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 29, 2019 | FUCITHALMIC | Amdipharm Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 29, 2019 | APO-GABAPENTIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 28, 2019 | TOUJEO SOLOSTAR / TOUJEO DOUBLESTAR | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 28, 2019 | IPG-DONEPEZIL | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 28, 2019 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES | Catalent Ontario Limited | Abbreviated New Drug Submission (ANDS) · Other |
| October 25, 2019 | ODEFSEY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 25, 2019 | DARZALEX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Priority |
| October 25, 2019 | APO-SULFATRIM ORAL SUSPENSION | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 25, 2019 | BALVERSA | Janssen Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 24, 2019 | PRO-AMOX-125; PRO-AMOX-250 | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| October 24, 2019 | APO-AMOXI CLAV | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 24, 2019 | XELJANZ; XELJANZ XR | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 23, 2019 | BERIPLEX P/N 1000; BERIPLEX P/N 500 | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2019 | BRENZYS (PEN); BRENZYS (PFS) | Samsung Bioepis Co., Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2019 | LEUCOVORIN | Avir Pharma Inc | Abbreviated New Drug Submission (ANDS) · Other |
| October 23, 2019 | TEVA-CARBAMAZEPINE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2019 | MEROPENEM FOR INJECTION | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 23, 2019 | SYNFLORIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 23, 2019 | ADEQUAN I.A. | American Regent, Inc | New Drug Submission (NDS) · Admin |
| October 23, 2019 | ADEQUAN I.M. | American Regent, Inc | New Drug Submission (NDS) · Admin |
| October 23, 2019 | ADEQUAN CANINE | American Regent, Inc | New Drug Submission (NDS) · Admin |
| October 22, 2019 | MINT-IMATINIB | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 21, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 18, 2019 | EVEROLIMUS | Novartis Pharmaceuticals Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| October 18, 2019 | LOVENOX | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | MINT-KETOROLAC | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 18, 2019 | BIACNA TOPICAL GEL | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| October 18, 2019 | PRO-CLONAZEPAM | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| October 18, 2019 | RABEPRAZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 18, 2019 | ACCUTANE ROCHE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | AURO-ATORVASTATIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 18, 2019 | APO-AMOXI | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | ZOMIG; ZOMIG RAPIMELT | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | METRONIDAZOLE INJECTION USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | ADVIL COLD & SINUS; ADVIL COLD & SINUS LIQUI-GELS; CHILDREN'S ADVIL COLD | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | ADMELOG | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | CEFADROXIL | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| October 18, 2019 | PMS-BORTEZOMIB | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 18, 2019 | CHILDREN'S MOTRIN; INFANTS' MOTRIN; MOTRIN LIQUID GELS 400 MG | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 18, 2019 | NETILDEX (WITH PRESERVATIVE); NETILDEX (WITHOUT PRESERVATIVE) | Knight Therapeutics Inc. | New Drug Submission (NDS) · Other |
| October 17, 2019 | AFLURIA TETRA | Seqirus Pty Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2019 | OVIDREL | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 16, 2019 | INFLUVAC TETRA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2019 | INFLUVAC TETRA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 16, 2019 | ALPROLIX | Bioverativ Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 15, 2019 | TARO-CEFPROZIL | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 15, 2019 | IBRANCE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 15, 2019 | ULTRAVATE | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| October 15, 2019 | CLAVAMOX DROPS | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 15, 2019 | CIDR 1380 | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 15, 2019 | IMOVAX RABIES | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| October 15, 2019 | NITISINONE TABLETS | Cycle Pharmaceuticals Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| October 11, 2019 | IBUPROFEN | JAMP Pharma Corporation | New Drug Submission (NDS) · Labelling Only |
| October 11, 2019 | COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 11, 2019 | RBX-ATORVASTATIN | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 11, 2019 | AURO-TRAMADOL | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 11, 2019 | FIRAZYR | Shire Orphan Therapies Llc | Supplement to a New Drug Submission (SNDS) · Other |
| October 11, 2019 | AA-FENO-MICRO; FENOFIBRATE | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| October 11, 2019 | PERICHLOR WITHOUT ALCOHOL | Pendopharm Division Of Pharmascience Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| October 10, 2019 | ESOMEPRAZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 10, 2019 | CEFPROZIL TABLETS | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 10, 2019 | TRI-JORDYNA 21; TRI-JORDYNA 28 | Glenmark Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 10, 2019 | CABOMETYX | Ipsen Biopharmaceuticals Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 10, 2019 | TRULANCE | Cipher Pharmaceuticals Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 10, 2019 | SPECTRO ECZEMACARE MEDICATED CREAM | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 9, 2019 | INFLUVAC TETRA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 9, 2019 | ATORVASTATIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| October 9, 2019 | OLIMEL 7.6%; OLIMEL 7.6% E | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| October 9, 2019 | PRZ-SOLIFENACIN | Pharmaris Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 9, 2019 | AURO-EMTRICITABINE-TENOFOVIR | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 9, 2019 | TARO-DOXORUBICIN LIPOSOMAL | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| October 8, 2019 | POTASSIUM CHLORIDE INJECTION | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 8, 2019 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| October 8, 2019 | NUCALA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2019 | VELTASSA | Vifor Fresenius Medical Care Renal Pharma Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 7, 2019 | NEXGARD | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| October 7, 2019 | NEXGARD | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| October 7, 2019 | NEXGARD | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| October 7, 2019 | NEXGARD | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| October 7, 2019 | MEN'S ROGAINE | Johnson & Johnson Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 4, 2019 | ISOVUE 200 INJECTION; ISOVUE 300 INJECTION; ISOVUE 370 INJECTION; ISOVUE MULTIPACK-300; ISOVUE MULTIPACK-370 | Bracco Imaging Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 4, 2019 | VELPHORO | Vifor Fresenius Medical Care Renal Pharma Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 4, 2019 | DYMISTA | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Other |
| October 4, 2019 | ACT DILTIAZEM XC | Actavis Pharma Company | Abbreviated New Drug Submission (ANDS) · Other |
| October 3, 2019 | ACT OXYCODONE CR | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| October 3, 2019 | SANDOZ LISINOPRIL HCT | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| October 3, 2019 | TEVA-PROPRANOLOL | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| October 3, 2019 | RADICAVA | Mitsubishi Tanabe Pharma Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| October 2, 2019 | ULORIC | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| October 2, 2019 | VENTIPULMIN | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| September 30, 2019 | RAN-RABEPRAZOLE | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | TARO-ADAPALENE/BENZOYL PEROXIDE | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 30, 2019 | RIVA-LEVOFLOXACIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 30, 2019 | VANIQA | Cipher Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 30, 2019 | ARSENIC TRIOXIDE FOR INJECTION | Sterimax Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | DOLMECTIN | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 30, 2019 | ACCEL-TROSPIUM | Accel Pharma Inc | Abbreviated New Drug Submission (ANDS) · Other |
| September 30, 2019 | TRANEXAMIC ACID INJECTION | Methapharm Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 30, 2019 | MOXIFLOXACIN OPHTHALMIC SOLUTION | Beximco Pharmaceuticals Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| September 27, 2019 | ACT LEVETIRACETAM | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| September 27, 2019 | ROBAX PLATINUM | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 27, 2019 | MINOCYCLINE | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| September 27, 2019 | ENTOCORT | Tillotts Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 27, 2019 | TEVA-SILDENAFIL R | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 27, 2019 | TARO-ADAPALENE/BENZOYL PEROXIDE | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| September 27, 2019 | CARBETOCIN INJECTION | Mda Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 27, 2019 | ACID CONTROL | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 27, 2019 | REACTINE; REACTINE ALLERGY LIQUID GELS; REACTINE FAST MELT JUNIOR; REACTINE RAPID DISSOLVE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 26, 2019 | BORTEZOMIB FOR INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 26, 2019 | ASPIRIN EXTRA STRENGTH | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 26, 2019 | ELIDEL | Valeant Canada Lp Valeant Canada S.E.C. | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2019 | AUBAGIO | Sanofi Genzyme, A Division Of Sanofi-Aventis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 26, 2019 | SIMPARICA TRIO | Zoetis Canada Inc | New Drug Submission (NDS) · Other |
| September 26, 2019 | SEDAJECT | Grey Wolf Animal Health Inc | Abbreviated New Drug Submission (ANDS) · Other |
| September 26, 2019 | ALLERTIN | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| September 26, 2019 | APO-MODAFINIL | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 26, 2019 | APO-CLOPIDOGREL | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 26, 2019 | APO-GATIFLOXACIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 25, 2019 | SANDOZ ATORVASTATIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 25, 2019 | SYMBICORT 100 TURBUHALER; SYMBICORT 200 TURBUHALER; SYMBICORT FORTE TURBUHALER | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 25, 2019 | FULVESTRANT INJECTION | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 25, 2019 | ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION; ONDANSETRON INJECTION USP; SANDOZ ONDANSETRON | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 25, 2019 | JAMP-METHOTREXATE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 25, 2019 | DULOXETINE | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 25, 2019 | BAQSIMI | Eli Lilly Canada Inc | New Drug Submission (NDS) · Other |
| September 25, 2019 | APO-LAMOTRIGINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 25, 2019 | MINT-ZOLPIDEM ODT | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 25, 2019 | DUPIXENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 25, 2019 | MINT-ZOLPIDEM ODT | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| September 25, 2019 | DAPTOMYCIN FOR INJECTION | Pfizer Canada Ulc | Abbreviated New Drug Submission (ANDS) · Other |
| September 24, 2019 | COLD + SINUS PLUS | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 24, 2019 | PRO-CEFUROXIME - 500 | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 24, 2019 | SANDOZ FLUVASTATIN XL | Sandoz Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| September 24, 2019 | JAMP METFORMIN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| September 24, 2019 | ASPIRIN REGULAR STRENGTH | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 24, 2019 | SOLIRIS | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Priority |
| September 23, 2019 | MOXIFLOXACIN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| September 23, 2019 | DESCOVY | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 23, 2019 | AG-RIZATRIPTAN ODT | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 20, 2019 | PRIVA-ZOPICLONE | Pharmapar Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 20, 2019 | TEVA-BROMAZEPAM | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 20, 2019 | SANDOZ OLOPATADINE | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 20, 2019 | RANITIDINE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| September 20, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 20, 2019 | IPG-CELECOXIB | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 20, 2019 | LENVIMA | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 20, 2019 | ACID CONTROL | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 19, 2019 | SSP+ | Maco Pharma | New Drug Submission (NDS) · Other |
| September 19, 2019 | SODIUM IODIDE I-123 ORAL SOLUTION | Bwxt Itg Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| September 19, 2019 | YF-VAX | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 19, 2019 | TECENTRIQ | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Priority |
| September 19, 2019 | MENACTRA | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 19, 2019 | ENTROPHEN | Pendopharm Division Of Pharmascience Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 19, 2019 | NEXIUM 24 HR | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 18, 2019 | FINACEA | Leo Pharma Inc | New Drug Submission (NDS) · Labelling Only |
| September 18, 2019 | MINT-IMATINIB | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| September 18, 2019 | METHOTREXATE TABLETS, USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 18, 2019 | NUVARING | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 18, 2019 | NERLYNX | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| September 18, 2019 | CIPROFLOXACIN TABLETS | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 18, 2019 | INFLECTRA | Celltrion Healthcare Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| September 17, 2019 | TEVA-FINGOLIMOD | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 17, 2019 | BELSOMRA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 17, 2019 | PROVOCHOLINE | Methapharm Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 13, 2019 | DIARRHEA RELIEF LIQUID GELS | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 13, 2019 | TRANEXAMIC ACID INJECTION BP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 13, 2019 | GENTAMICIN(E) | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 13, 2019 | APO-TRAMADOL | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 13, 2019 | PRO-AMOX-250; PRO-AMOX-500 | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| September 13, 2019 | PMS-LOPERAMIDE; PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 12, 2019 | MINT-ITRACONAZOLE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 12, 2019 | PDP-AMANTADINE HYDROCHLORIDE CAPSULES; PDP-AMANTADINE HYDROCHLORIDE SYRUP | Pendopharm Division Of Pharmascience Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 12, 2019 | APO-ATORVASTATIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 12, 2019 | JAMP-CELECOXIB | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 12, 2019 | ZAVESCA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 11, 2019 | TARO-ROSUVASTATIN | Sun Pharma Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 11, 2019 | TEVA-ESOMEPRAZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 11, 2019 | CEFAZOLIN FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 11, 2019 | AMLODIPINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| September 11, 2019 | CARIPUL | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 11, 2019 | FLUVIRAL | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Other |
| September 11, 2019 | FLULAVAL TETRA | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Other |
| September 11, 2019 | CALDOLOR | Cumberland Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| September 11, 2019 | FLUZONE QUADRIVALENT | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 11, 2019 | FLUZONE HIGH-DOSE | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 11, 2019 | ENTROPHEN CHEWABLE | Pendopharm Division Of Pharmascience Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 11, 2019 | ASPIRIN 81 MG | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 11, 2019 | ERTAPENEM FOR INJECTION | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 10, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 10, 2019 | FLUAD; FLUAD PEDIATRIC | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 10, 2019 | AGRIFLU | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 10, 2019 | TRACLEER | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 10, 2019 | EXELON PATCH | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2019 | COLD + SINUS | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 9, 2019 | CEFUROXIME FOR INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 9, 2019 | KISQALI | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2019 | SANDOZ ADAPALENE/BENZOYL PEROXIDE | Sandoz Canada Inc. | New Drug Submission (NDS) · Admin |
| September 9, 2019 | ODAN LEVOCARNITINE | Odan Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| September 6, 2019 | PROSCAR | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 6, 2019 | HYDROMORPHONE HYDROCHLORIDE INJECTION HP 10; HYDROMORPHONE HYDROCHLORIDE INJECTION HP 50; HYDROMORPHONE HYDROCHLORIDE INJECTION HP FORTE | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 6, 2019 | INVOKANA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 6, 2019 | KYPROLIS | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 6, 2019 | TALZENNA | Pfizer Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| September 6, 2019 | JAMP RASAGILINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| September 6, 2019 | RAN-DULOXETINE | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 6, 2019 | ZOLEDRONIC ACID-Z | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 6, 2019 | DOCETAXEL INJECTION | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 5, 2019 | PMS-VARENICLINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 5, 2019 | SANDOZ EFAVIRENZ/EMTRICITABINE/TENOFOVIR | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 5, 2019 | FONDAPARINUX SODIUM INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 5, 2019 | NRA-CIPROFLOXACIN | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 5, 2019 | SANDOZ EMTRICITABINE-TENOFOVIR | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 5, 2019 | TYLAN SOLUBLE | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| September 4, 2019 | DUPIXENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 4, 2019 | SANDOZ CANDESARTAN PLUS | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 4, 2019 | PMS-BICALUTAMIDE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 4, 2019 | APO-DABIGATRAN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 4, 2019 | PROPECIA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 3, 2019 | HERZUMA | Celltrion Healthcare Co Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 3, 2019 | HERZUMA | Celltrion Healthcare Co Ltd | New Drug Submission (NDS) · Other |
| September 3, 2019 | ENALAPRILAT INJECTION USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 3, 2019 | PMS-ZOLMITRIPTAN ODT | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| September 3, 2019 | LEMTRADA | Sanofi Genzyme, A Division Of Sanofi-Aventis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2019 | METRONIDAZOLE INJECTION, USP | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| September 3, 2019 | INFANRIX-HEXA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2019 | INFANRIX-IPV/HIB | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2019 | HIBERIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2019 | PRIORIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 3, 2019 | PRIORIX-TETRA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 30, 2019 | ZERBAXA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| August 30, 2019 | LUPIN-PROPRANOLOL LA | Lupin Pharma Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| August 30, 2019 | TELMISARTAN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 30, 2019 | INTUNIV XR | Shire Pharma Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 30, 2019 | PLAQUENIL | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 29, 2019 | TEVA-DULOXETINE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| August 29, 2019 | MINT-CELECOXIB | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 29, 2019 | ACH-LETROZOLE | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 28, 2019 | AURO-LEVOFLOXACIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 28, 2019 | INFLECTRA | Celltrion Healthcare Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| August 28, 2019 | ULTOMIRIS | Alexion Pharma Gmbh | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 27, 2019 | CLINDAMYCINE-150; CLINDAMYCINE-300 | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 27, 2019 | APO-LORATADINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 27, 2019 | SUMMIT ULTRA | Pendopharm Division Of Pharmascience Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 23, 2019 | PRIVA-CIPROFLOXACIN | Pharmapar Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 23, 2019 | NAT-GEFITINIB | Natco Pharma (Canada) Inc | Abbreviated New Drug Submission (ANDS) · Other |
| August 23, 2019 | CALQUENCE | Astrazeneca Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 23, 2019 | 24HR NASAL ALLERGY RELIEF | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 23, 2019 | IMFINZI | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 23, 2019 | VITRECTO | Intervet Canada Corp | New Drug Submission (NDS) · Other |
| August 23, 2019 | ATIPAM | Eurovet Animal Health B V | Abbreviated New Drug Submission (ANDS) · Other |
| August 22, 2019 | ENABLEX | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 22, 2019 | MAR-ATORVASTATIN | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 22, 2019 | TEVA-PROPOFOL | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| August 22, 2019 | APO-EZETIMIBE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| August 22, 2019 | DOVATO | Viiv Healthcare Ulc | New Drug Submission (NDS) · Other |
| August 22, 2019 | HYDROMORPHONE HYDROCHLORIDE INJECTION, USP | Fresenius Kabi Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| August 21, 2019 | SANDOZ GATIFLOXACIN | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 21, 2019 | APO-METHOTREXATE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 21, 2019 | DELSTRIGO | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 21, 2019 | HYDROMORPHONE HYDROCHLORIDE INJECTION, USP | Fresenius Kabi Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| August 20, 2019 | UPTRAVI | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 20, 2019 | SANDOZ LINEZOLID | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 19, 2019 | FLUAD; FLUAD PEDIATRIC | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 19, 2019 | AGRIFLU | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 16, 2019 | ACTEMRA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 16, 2019 | DALACIN T | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 16, 2019 | BENAZEPRIL | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 16, 2019 | ICLUSIG | Ariad Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 16, 2019 | JINARC | Otsuka Pharmaceutical Co Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 16, 2019 | PMS-RAMIPRIL-HCTZ | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 16, 2019 | HEARTGARD-30 PLUS | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| August 16, 2019 | HEARTGARD-30 PLUS | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| August 16, 2019 | HEARTGARD-30 PLUS | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| August 16, 2019 | NYSTATIN/ COLISTIN/ TOBRAMYCIN | Sunnybrook Research Institute | New Drug Submission (NDS) · Other |
| August 15, 2019 | TRULICITY | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 15, 2019 | NAT-QUETIAPINE | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 15, 2019 | PRO-CLONAZEPAM | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| August 15, 2019 | CARBAMAZEPINE CR | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| August 15, 2019 | TRAZIMERA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 15, 2019 | STELARA I.V. | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 15, 2019 | TRAZIMERA | Pfizer Canada Ulc | New Drug Submission (NDS) · Other |
| August 15, 2019 | APO-TRAMADOL | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 15, 2019 | CYCLOSOL 200 LA | Eurovet Animal Health B V | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 14, 2019 | ALLOPURINOL-100; ALLOPURINOL-200; ALLOPURINOL-300 | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| August 14, 2019 | ULTRACAINE D-S FORTE INJECTION; ULTRACAINE D-S INJECTION | Hansamed Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 14, 2019 | AURO-ONDANSETRON INJECTION | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 13, 2019 | REVESTIVE | Shire Pharmaceuticals Ireland Limited | Supplement to a New Drug Submission (SNDS) · Priority |
| August 13, 2019 | DALACIN C PHOSPHATE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2019 | DALACIN C FLAVOURED GRANULES | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2019 | DALACIN C | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2019 | FULVESTRANT INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 12, 2019 | OPSUMIT | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 12, 2019 | CARBAGLU | Recordati Rare Diseases | New Drug Submission (NDS) · Admin |
| August 12, 2019 | LOVENOX; LOVENOX HP | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2019 | DRAXXIN | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2019 | LENVIMA | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 9, 2019 | JAMP HYDROXYCHLOROQUINE SULFATE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| August 9, 2019 | PROSTIN VR STERILE SOLUTION | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 9, 2019 | RAN-CELECOXIB | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 9, 2019 | CLAVULIN | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 9, 2019 | ACETYLCYSTEINE INJECTION | Teligent Ou | Abbreviated New Drug Submission (ANDS) · Admin |
| August 9, 2019 | PRO-RAMIPRIL-1.25; PRO-RAMIPRIL-10; PRO-RAMIPRIL-2.5; PRO-RAMIPRIL-5 | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 9, 2019 | APO-SALBUTAMOL HFA | Apotex Inc. | New Drug Submission (NDS) · Admin |
| August 9, 2019 | CARNITOR | Leadiant Biosciences, Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 9, 2019 | JAMP FINGOLIMOD | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| August 8, 2019 | TECENTRIQ | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Priority |
| August 8, 2019 | KEVZARA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 8, 2019 | TEVA-PANTOPRAZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 8, 2019 | PREVNAR 13 | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 7, 2019 | TAGRISSO | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 7, 2019 | MAR-METRONIDAZOLE | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 7, 2019 | METHOTREXATE SUBCUTANEOUS | Accord Healthcare Inc | Abbreviated New Drug Submission (ANDS) · Other |
| August 6, 2019 | IBRANCE | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| August 6, 2019 | REPAGLINIDE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 6, 2019 | AG-FINASTERIDE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 6, 2019 | VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 6, 2019 | ZOLEDRONIC ACID INJECTION | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 6, 2019 | TEVA-TERIPARATIDE INJECTION | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| August 2, 2019 | APO-LEVOCARB | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 2, 2019 | SANDOZ FENTANYL PATCH | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| August 2, 2019 | SAIZEN | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 2, 2019 | MYLAN-CYPROTERONE / ETHINYL ESTRADIOL | Mylan Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Other |
| August 2, 2019 | APO-FLUCONAZOLE-150 | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 1, 2019 | DIARRHEA RELIEF | Vita Health Products Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 1, 2019 | VOTRIENT | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 1, 2019 | MINT-CETIRIZINE | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| August 1, 2019 | TUSSIONEX | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| August 1, 2019 | SELANOR | Norbrook Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| August 1, 2019 | AURO-CELECOXIB | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 31, 2019 | APO-FINGOLIMOD | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| July 31, 2019 | TEVA-ZOLMITRIPTAN; TEVA-ZOLMITRIPTAN OD | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 31, 2019 | RBX-CELECOXIB | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 31, 2019 | PRALUENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 31, 2019 | CEFAZOLIN FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 31, 2019 | MESNA FOR INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 30, 2019 | EMGALITY | Eli Lilly Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 30, 2019 | CYRAMZA | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 30, 2019 | DEXILANT | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| July 30, 2019 | MINT-LEVOCARB | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 30, 2019 | POMALYST | Celgene Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2019 | SANDOZ TACROLIMUS | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 29, 2019 | NOVORAPID | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2019 | CEFTRIAXONE SODIUM FOR INJECTION BP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 29, 2019 | ACTEMRA SC | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2019 | ACH-IMATINIB | Accord Healthcare Inc | Abbreviated New Drug Submission (ANDS) · Other |
| July 29, 2019 | ATAJECT | Grey Wolf Animal Health Inc | Abbreviated New Drug Submission (ANDS) · Other |
| July 29, 2019 | INHIBACE | Cheplapharm Arzneimittel Gmbh Germany | New Drug Submission (NDS) · Labelling Only |
| July 29, 2019 | MYLAN-LANSOPRAZOLE FDT | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 29, 2019 | MYLAN-LANSOPRAZOLE FDT | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 29, 2019 | MYLAN-LANSOPRAZOLE FDT | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 29, 2019 | MYLAN-LANSOPRAZOLE FDT | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 26, 2019 | CLOZARIL | Hls Therapeutics Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 26, 2019 | AFLURIA TETRA | Seqirus Pty Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 26, 2019 | CANESORAL COMBI 1 DAY | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 26, 2019 | CANESTEN EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 26, 2019 | AURO-CEFPROZIL | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 26, 2019 | ISTODAX | Celgene Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2019 | BRIMONIDINE P | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 25, 2019 | DIFLUCAN ONE | Pfizer Canada Ulc | New Drug Submission (NDS) · Admin |
| July 25, 2019 | TEVA-TRYPTOPHAN | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 25, 2019 | ATORVASTATIN-10; ATORVASTATIN-20; ATORVASTATIN-40; ATORVASTATIN-80 | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 25, 2019 | DULOXETINE | Sanis Health Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| July 25, 2019 | CEFOTAXIME SODIUM FOR INJECTION, BP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 25, 2019 | AURO-PERINDOPRIL | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 25, 2019 | APO-LAMIVUDINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 25, 2019 | JAMP-FEBUXOSTAT | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| July 25, 2019 | RIVOTRIL | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 25, 2019 | COSENTYX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 25, 2019 | LOKELMA | Astrazeneca Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 25, 2019 | ODAN CLOBETASOL SPRAY | Odan Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| July 24, 2019 | PMS-CELECOXIB | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 24, 2019 | APO-CLONAZEPAM | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 24, 2019 | SEROSTIM | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 24, 2019 | PRAVASTATIN | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 24, 2019 | TNKASE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 24, 2019 | ACTIVASE RT-PA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 24, 2019 | ERTAPENEM FOR INJECTION | Mda Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 23, 2019 | AMLODIPINE | Altamed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| July 23, 2019 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | Dr Reddys Laboratories Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 23, 2019 | KETOROLAC TROMETHAMINE INJECTION, USP | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 23, 2019 | DEXEDRINE SPANSULE | Paladin Labs Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 23, 2019 | PENTACEL | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 23, 2019 | QUADRACEL | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2019 | OZURDEX | Allergan Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 22, 2019 | ESTROGEL | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2019 | TOBI PODHALER | BGP Pharma ULC | New Drug Submission (NDS) · Admin |
| July 22, 2019 | TRUXIMA | Celltrion Healthcare Co Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 22, 2019 | NEXGARD SPECTRA | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| July 22, 2019 | NEXGARD SPECTRA | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| July 22, 2019 | NEXGARD SPECTRA | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| July 22, 2019 | NEXGARD SPECTRA | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| July 22, 2019 | NEXGARD SPECTRA | Boehringer Ingelheim Animal Health Canada Inc. | New Drug Submission (NDS) · Admin |
| July 19, 2019 | BERIPLEX P/N 1000; BERIPLEX P/N 500 | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 19, 2019 | CETROTIDE | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 19, 2019 | SIGNIFOR LAR | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 19, 2019 | EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES; IBUPROFEN LIQUID GEL CAPSULES | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 19, 2019 | GENVOYA | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 19, 2019 | TOBI | BGP Pharma ULC | New Drug Submission (NDS) · Admin |
| July 19, 2019 | OMEPRAZOLE | Altamed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| July 19, 2019 | ZOLEDRONIC ACID FOR INJECTION | Mda Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 17, 2019 | ADCETRIS | Seattle Genetics Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 17, 2019 | TRAVATAN Z | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 17, 2019 | ACT CITALOPRAM | Sunovion Pharmaceuticals Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| July 17, 2019 | ACT CITALOPRAM | Sunovion Pharmaceuticals Canada Inc | New Drug Submission (NDS) · Admin |
| July 17, 2019 | ZEULIDE DEPOT | Verity Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| July 17, 2019 | PAT-GALANTAMINE ER | Janssen Inc. | New Drug Submission (NDS) · Admin |
| July 17, 2019 | PMS-FENTANYL MTX | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| July 17, 2019 | FLUOXETINE | Altamed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| July 17, 2019 | JAMP METHIMAZOLE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| July 17, 2019 | JAMP ONDANSETRON | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| July 17, 2019 | PRIVA-DUTASTERIDE | Pharmapar Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 16, 2019 | NERLYNX | Puma Biotechnology Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 15, 2019 | PMS-ATOMOXETINE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 15, 2019 | MINT-LACOSAMIDE | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| July 15, 2019 | SUTENT | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 12, 2019 | PRO-NAPROXEN EC | Pro Doc Limitee | New Drug Submission (NDS) · Labelling Only |
| July 12, 2019 | PROBUPHINE | Knight Therapeutics Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 11, 2019 | DORZOLAMIDE AND TIMOLOL EYE DROPS BP | Teligent Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| July 11, 2019 | LATANOPROST OPHTHALMIC SOLUTION | Teligent Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| July 11, 2019 | LATANOPROST AND TIMOLOL OPHTHALMIC SOLUTION | Teligent Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| July 11, 2019 | SANDOZ CELECOXIB | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 11, 2019 | PDP-LEVETIRACETAM | Pendopharm Division Of Pharmascience Inc | New Drug Submission (NDS) · Other |
| July 11, 2019 | APO-QUINAPRIL | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 11, 2019 | CISPLATIN INJECTION, BP | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 11, 2019 | BOOSTRIX-POLIO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 11, 2019 | PRIVA-DULOXETINE | Pharmapar Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 11, 2019 | ACH-PREGABALIN | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 11, 2019 | DARZALEX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 11, 2019 | DACOGEN | Otsuka Pharmaceutical Co Ltd | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 11, 2019 | PLAN B | Foundation Consumer Healthcare, Llc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 10, 2019 | DORZOLAMIDE EYE DROPS BP | Teligent Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| July 10, 2019 | VITRAKVI | Bayer Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 10, 2019 | JAMP-DOXAZOSIN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| July 10, 2019 | NRA-MONTELUKAST | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 10, 2019 | ETIBI | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| July 10, 2019 | APO-CELECOXIB | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 10, 2019 | INLYTA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 9, 2019 | METHOTREXATE INJECTION USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 9, 2019 | VOLIBRIS | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 8, 2019 | JAMP-SILDENAFIL R | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 8, 2019 | VYVANSE | Shire Pharma Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| July 8, 2019 | RASILEZ HCT | Noden Pharma Dac | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 5, 2019 | PRIVA-RIVASTIGMINE | Pharmapar Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 5, 2019 | TEVA-ATOMOXETINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 5, 2019 | PMS-NABILONE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 5, 2019 | OPTICROM | Allergan Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 5, 2019 | APO-IBUPROFEN CAPLET | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 5, 2019 | SUBLINOX | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| July 5, 2019 | FLUOXETINE | Sivem Pharmaceuticals Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 5, 2019 | APO-GABAPENTIN | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| July 5, 2019 | ELETRIPTAN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| July 5, 2019 | INTRON A | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 4, 2019 | ESPEROCT | Novo Nordisk Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 4, 2019 | MESTINON; MESTINON-SR | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| July 4, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 4, 2019 | ACH-EZETIMIBE | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| July 4, 2019 | FERRIPROX | Apopharma Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 4, 2019 | TEVA-SERTRALINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 3, 2019 | M-LANSOPRAZOLE | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| July 3, 2019 | CORTROSYN | Amphastar Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| July 3, 2019 | DESFERAL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 3, 2019 | NETSPOT | Advanced Accelerator Applications Usa, Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| July 2, 2019 | ROFACT | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| July 2, 2019 | POMALYST | Celgene Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 2, 2019 | SANDOZ DEFERASIROX (TYPE J) | Sandoz Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| July 2, 2019 | VYLOMA | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| July 2, 2019 | ZOFRAN | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 28, 2019 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION | Curium Canada Inc | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| June 28, 2019 | TEVA-CITALOPRAM | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 28, 2019 | ATACAND PLUS | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 28, 2019 | TELMISARTAN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 28, 2019 | ACETYLCYSTEINE INJECTION | Alveda Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| June 28, 2019 | MEROPENEM FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 28, 2019 | FIRAZYR | Shire Orphan Therapies Llc | Supplement to a New Drug Submission (SNDS) · Other |
| June 28, 2019 | RABEPRAZOLE EC | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 28, 2019 | INHIBACE PLUS | Cheplapharm Arzneimittel Gmbh Germany | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 28, 2019 | ZEPATIER | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 28, 2019 | TRILEPTAL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 28, 2019 | ZESTORETIC | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 27, 2019 | M-DULOXETINE | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 27, 2019 | DORZOLAMIDE AND TIMOLOL EYE DROPS BP | Teligent Pharma, Inc . | Abbreviated New Drug Submission (ANDS) · Admin |
| June 27, 2019 | NRA-ZOLMITRIPTAN | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 27, 2019 | ACYCLOVIR SODIUM INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 27, 2019 | VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP | Generic Medical Partners Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 27, 2019 | ZEJULA | Glaxosmithkline Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| June 27, 2019 | JAMP-KETOTIFEN | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| June 26, 2019 | LUPRON; LUPRON DEPOT | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 26, 2019 | MINT-SPIRONOLACTONE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 26, 2019 | APO-LISINOPRIL/HCTZ | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 26, 2019 | TOPICORT; TOPICORT GEL; TOPICORT MILD; TOPICORT OINTMENT | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| June 26, 2019 | VERAPAMIL HYDROCHLORIDE INJECTION USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 26, 2019 | CELLCEPT; CELLCEPT I.V. | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 25, 2019 | AG-OLANZAPINE FC | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 25, 2019 | LUPRON DEPOT | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 25, 2019 | LUPRON; LUPRON DEPOT | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 25, 2019 | METHIMAZOLE TABLETS USP | Endo Ventures Ltd | New Drug Submission (NDS) · Labelling Only |
| June 25, 2019 | LESCOL XL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 25, 2019 | MAVIRET | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Priority |
| June 25, 2019 | CERENIA | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2019 | LETROZOLE SUN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 24, 2019 | IBUPROFEN CAPSULES, 200 MG; IBUPROFEN CAPSULES, 400 MG | Catalent Ontario Limited | Abbreviated New Drug Submission (ANDS) · Other |
| June 21, 2019 | TEVA-MONTELUKAST | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 21, 2019 | ACCEL-ENTECAVIR | Accel Pharma Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| June 21, 2019 | ICLUSIG | Ariad Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 20, 2019 | ADDYI | Sprout Pharmaceuticals Canada, Ltd | New Drug Submission (NDS) · Admin |
| June 20, 2019 | LATANOPROST OPHTHALMIC SOLUTION | Teligent Pharma, Inc . | Abbreviated New Drug Submission (ANDS) · Admin |
| June 20, 2019 | LORATADINE SOFT GEL CAPSULES | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 20, 2019 | TECHNELITE | Lantheus Mi Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2019 | JAMP-SIMVASTATIN | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 19, 2019 | TECFIDERA | Biogen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2019 | VENLAFAXINE XR | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 19, 2019 | GARDASIL 9 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2019 | CLAVAMOX | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 19, 2019 | TALTZ | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 18, 2019 | IDELVION | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 18, 2019 | ALDARA P | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| June 18, 2019 | TARO-CLOBETASOL SPRAY | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| June 18, 2019 | SANDOZ ATORVASTATIN | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 18, 2019 | LATANOPROST AND TIMOLOL OPHTHALMIC SOLUTION | Teligent Pharma, Inc . | Abbreviated New Drug Submission (ANDS) · Admin |
| June 18, 2019 | XEOMIN COSMETIC | Merz Pharmaceuticals Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| June 18, 2019 | FEIBA NF | Shire Pharma Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 17, 2019 | VANCOMYCIN HYDROCHLORIDE CAPSULES, USP | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| June 17, 2019 | AA-CLOZAPINE | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 17, 2019 | EVENITY | Amgen Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| June 14, 2019 | HEMLIBRA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Priority |
| June 14, 2019 | ZIRABEV | Pfizer Canada Ulc | New Drug Submission (NDS) · Other |
| June 14, 2019 | HYZAAR; HYZAAR DS | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 14, 2019 | POSANOL | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 14, 2019 | VASERETIC | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 14, 2019 | TEVA-LANSOPRAZOLE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 14, 2019 | FOSAPREPITANT | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 14, 2019 | TEVA-CANDESARTAN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 14, 2019 | AURO-CLOZAPINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 13, 2019 | ARIDOL | Pharmaxis Ltd | New Drug Submission (NDS) · Other |
| June 13, 2019 | NERFASIN 20 | Dechra Regulatory Bv | Abbreviated New Drug Submission (ANDS) · Admin |
| June 13, 2019 | NERFASIN 100 | Dechra Regulatory Bv | Abbreviated New Drug Submission (ANDS) · Admin |
| June 13, 2019 | NRA-RIZATRIPTAN ODT | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 13, 2019 | FOSFOMYCIN POWDER FOR ORAL SOLUTION | Endo Ventures Ltd | New Drug Submission (NDS) · Labelling Only |
| June 13, 2019 | CETROTIDE | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| June 13, 2019 | FULVESTRANT INJECTION | Accord Healthcare Inc | Abbreviated New Drug Submission (ANDS) · Other |
| June 12, 2019 | ZONOVATE | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 12, 2019 | SELEXID | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| June 12, 2019 | AURO-ZIPRASIDONE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 11, 2019 | LIBRAX | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| June 11, 2019 | ALLOPURINOL | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 11, 2019 | ESCITALOPRAM | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 11, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2019 | TEVA-CANDESARTAN/HCTZ | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 11, 2019 | ILEVRO | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 11, 2019 | RIVA-LABETALOL | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 10, 2019 | DORZOLAMIDE EYE DROPS BP | Teligent Pharma, Inc . | Abbreviated New Drug Submission (ANDS) · Admin |
| June 10, 2019 | LUVERIS | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 10, 2019 | OMNISCAN | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 10, 2019 | AA-AMILZIDE | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 10, 2019 | CEPESEDAN | Modern Veterinary Therapeutics Llc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 10, 2019 | AURO-SILDENAFIL | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 10, 2019 | MOTRIN 200 MG; MOTRIN 300 MG; MOTRIN 400 MG; MOTRIN LIQUID GELS 200 MG | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 10, 2019 | MOTRIN PLATINUM MUSCLE & BODY | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 10, 2019 | TEGRETOL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2019 | TEVA-VALGANCICLOVIR | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 10, 2019 | ACH-LACOSAMIDE | Accord Healthcare Inc | Abbreviated New Drug Submission (ANDS) · Other |
| June 7, 2019 | BOTOX | Allergan Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 7, 2019 | SILIQ | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| June 7, 2019 | ENALAPRIL MALEATE/HCTZ | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 7, 2019 | ONPATTRO | Alnylam Netherlands B.V. | New Drug Submission (NDS) · Priority-NAS |
| June 7, 2019 | DOBUTAMINE INJECTION USP | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 7, 2019 | ORILISSA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 7, 2019 | CARBETOCIN INJECTION | Mda Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 6, 2019 | SANDOZ RABEPRAZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| June 6, 2019 | VISKAZIDE | Aralez Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 6, 2019 | APO-TRIAZIDE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 6, 2019 | POLYFLEX | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2019 | MVASI | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2019 | 3TC | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2019 | VIMIZIM | Biomarin International Limited | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2019 | HUMIRA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 5, 2019 | JAMP-VARDENAFIL ODT | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| June 5, 2019 | MARVELON 21; MARVELON 28 | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 4, 2019 | METHOTREXATE INJECTION, BP | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| June 4, 2019 | ASN-RASAGILINE | Ascend Laboratories Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| June 4, 2019 | ALOXI | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| June 4, 2019 | LIPITOR | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 4, 2019 | PRALUENT | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 3, 2019 | CAYSTON | Gilead Sciences Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| June 3, 2019 | ERFA-AMIKACIN | Erfa Canada 2012 Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 3, 2019 | DUTASTERIDE CAPSULES | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| June 3, 2019 | CARBOLITH | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| May 31, 2019 | PEPCID COMPLETE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 31, 2019 | MAXIMUM STRENGTH PEPCID AC; PEPCID AC | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 31, 2019 | IMODIUM CALMING LIQUID; IMODIUM LIQUI-GELS; IMODIUM QUICK DISSOLVE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 31, 2019 | NUTROPIN AQ | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 31, 2019 | ROCURONIUM BROMIDE INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 31, 2019 | TEVA-ABACAVIR/LAMIVUDINE | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 31, 2019 | ARSENIC TRIOXIDE SOLUTION FOR INJECTION | Phebra Pty Ltd | Abbreviated New Drug Submission (ANDS) · Admin |
| May 31, 2019 | TARO-LORATADINE | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 31, 2019 | CYTOMEL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| May 30, 2019 | SEASONIQUE | Teva Womens Health Inc. Subsidiary Of Teva Pharmaceuticals Usa Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 30, 2019 | PMS-BOSENTAN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 30, 2019 | NORVIR | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 29, 2019 | ALECENSARO | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 29, 2019 | IMODIUM COMPLETE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 29, 2019 | SEASONALE | Teva Womens Health Inc. Subsidiary Of Teva Pharmaceuticals Usa Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 29, 2019 | GLUCAGEN; GLUCAGEN HYPOKIT | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 29, 2019 | DRY-CLOX | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2019 | AMLODIPINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| May 28, 2019 | APO-LEVOCARB CR | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 28, 2019 | OLMETEC PLUS | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 28, 2019 | STEGLUJAN | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2019 | ASMANEX TWISTHALER | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2019 | ZITHROMAX | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| May 27, 2019 | PRIVIGEN | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 27, 2019 | NRA-PERINDOPRIL | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 27, 2019 | METHOTREXATE INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 27, 2019 | PERINDOPRIL ERBUMINE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| May 27, 2019 | SUFENTANIL CITRATE INJECTION USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 27, 2019 | CESAMET | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Admin |
| May 27, 2019 | JAMP-EFAVIRENZ | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 27, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 27, 2019 | CLARITIN RAPID DISSOLVE | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 27, 2019 | CLARITIN KIDS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 24, 2019 | KETAMINE HYDROCHLORIDE INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 24, 2019 | REACTINE COMPLETE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 24, 2019 | CLARITIN ALLERGY | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 24, 2019 | DATSCAN | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 24, 2019 | GALDERMA ADAPALENE/BENZOYL PEROXIDE | Galderma Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| May 24, 2019 | JENTADUETO | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 24, 2019 | AURO-AMOXICILLIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 24, 2019 | TECENTRIQ | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 23, 2019 | CARBOPLATIN INJECTION BP | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 23, 2019 | BURINEX | Knight Therapeutics Inc. | New Drug Submission (NDS) · Admin |
| May 23, 2019 | BUPIVACAINE HYDROCHLORIDE INJECTION, USP | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 22, 2019 | TRAJENTA | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 22, 2019 | TRANDOLAPRIL | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| May 22, 2019 | DICLECTIN | Duchesnay Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 22, 2019 | NAT-ONDANSETRON | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 22, 2019 | SANDOZ FENTANYL PATCH | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 22, 2019 | AURO-AZITHROMYCIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 22, 2019 | CLADRIBINE INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 21, 2019 | PROLASTIN-C LIQUID / PROLASTIN-C | Grifols Therapeutics Llc | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2019 | CLARITIN LIQUID CAPSULES | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 21, 2019 | AG-LOSARTAN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 21, 2019 | PMS-METHOTREXATE | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 21, 2019 | OLMESARTAN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| May 21, 2019 | FUROSEMIDE INJECTION, USP | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 21, 2019 | JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 17, 2019 | APO-ABACAVIR-LAMIVUDINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| May 17, 2019 | MYOVIEW 30 ML | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 17, 2019 | MYOVIEW | Ge Healthcare Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 17, 2019 | CLARITIN ALLERGY + SINUS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 16, 2019 | RABEPRAZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 16, 2019 | CLINDAMYCIN INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 16, 2019 | CLARITIN ALLERGY + SINUS EXTRA STRENGTH | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 16, 2019 | JAMP-FINASTERIDE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 15, 2019 | ACCUTANE ROCHE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 15, 2019 | GLYXAMBI | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 15, 2019 | STELARA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2019 | PRIVIGEN | Csl Behring Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2019 | REVOLADE | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2019 | SHINGRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 15, 2019 | OCTREOSCAN | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| May 14, 2019 | ORILISSA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2019 | APO-PREGABALIN | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| May 14, 2019 | BAVENCIO | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2019 | AERIUS KIDS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 14, 2019 | AERIUS DOUBLE ACTION 12 HOUR | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 13, 2019 | AG-CELECOXIB | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 13, 2019 | MINT-TELMISARTAN | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 13, 2019 | APO-ALLOPURINOL | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| May 10, 2019 | ULTRATAG RBC | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| May 10, 2019 | APO-METHOTREXATE | Apotex Inc. | New Drug Submission (NDS) · Admin |
| May 10, 2019 | APO-VENLAFAXINE XR | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 10, 2019 | MAR-TROSPIUM | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 10, 2019 | JAMP-LACOSAMIDE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| May 10, 2019 | TIBELLA | BioSyent Pharma Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| May 10, 2019 | AERIUS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 10, 2019 | NAPROXEN CAPSULES 200 MG | Apotex Inc. | New Drug Submission (NDS) · Labelling Only |
| May 9, 2019 | ACT CITALOPRAM | Teva Canada Limited | New Drug Submission (NDS) · Admin |
| May 9, 2019 | NRA-SERTRALINE | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 9, 2019 | COMBOGESIC | Aft Pharmaceuticals Ltd | New Drug Submission (NDS) · Other |
| May 9, 2019 | APO-PERINDOPRIL/AMLODIPINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 7, 2019 | CHAMPIX | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 7, 2019 | NORITATE | Bausch Health, Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| May 7, 2019 | OSPHOS INJECTION | Dechra Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| May 7, 2019 | SOMATULINE AUTOGEL | Ipsen Biopharm Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 6, 2019 | ENTYVIO | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2019 | ESOMEPRAZOLE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| May 6, 2019 | IMBRUVICA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2019 | LYNPARZA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Priority |
| May 3, 2019 | LINESSA 21; LINESSA 28 | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 3, 2019 | VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 3, 2019 | GONAL-F; GONAL-F PEN | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 3, 2019 | OLANZAPINE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| May 3, 2019 | APO-DOXAZOSIN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 3, 2019 | MINT-SPIRONOLACTONE | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| May 3, 2019 | M-MONTELUKAST | Mantra Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2019 | OGIVRI | BGP Pharma ULC | New Drug Submission (NDS) · Other |
| May 3, 2019 | YERVOY | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 2, 2019 | ADCETRIS | Seattle Genetics Inc | Supplement to a New Drug Submission (SNDS) · Other |
| May 1, 2019 | CANESTEN EXTERNAL ANTIFUNGAL CREAM | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| May 1, 2019 | ARIPIPRAZOLE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| May 1, 2019 | APO-RANITIDINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| May 1, 2019 | HYDROMORPHONE HP 10; HYDROMORPHONE HP 20; HYDROMORPHONE HP 50; HYDROMORPHONE HP FORTE | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Priority |
| May 1, 2019 | IVOZFO | Verity Pharmaceuticals Inc | New Drug Submission (NDS) · Priority |
| April 30, 2019 | CEFUROXIME FOR INJECTION, USP | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 30, 2019 | APO-MONTELUKAST | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| April 30, 2019 | AA-THEO LA | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| April 29, 2019 | VIBERZI | Allergan Inc | New Drug Submission (NDS) · Admin |
| April 29, 2019 | RIVA-ANASTROZOLE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 29, 2019 | LEVOFLOXACIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 29, 2019 | TIVICAY | Viiv Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 29, 2019 | DEPAKENE | BGP Pharma ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 26, 2019 | FLULAVAL TETRA | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 26, 2019 | FLUVIRAL | Id Biomedical Corporation Of Quebec | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 26, 2019 | REVERTOR | Modern Veterinary Therapeutics Llc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 26, 2019 | PMS-BUPRENORPHINE-NALOXONE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 26, 2019 | ORENCIA | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 26, 2019 | MABCAMPATH | Sanofi Genzyme, A Division Of Sanofi-Aventis Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 26, 2019 | LANSOPRAZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 26, 2019 | LANSOPRAZOLE | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 26, 2019 | THALLOUS CHLORIDE TI-201 INJECTION | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| April 26, 2019 | HIGH PURITY INDIUM CHLORIDE IN 111 STERILE SOLUTION | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| April 26, 2019 | TECHNESCAN MAG3 | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| April 26, 2019 | GALLIUM (GA67) CITRATE INJECTION | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| April 26, 2019 | CLARITHROMYCIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 26, 2019 | MAR-LACOSAMIDE | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 25, 2019 | BIVALIRUDIN FOR INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 24, 2019 | ACT FLUVOXAMINE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| April 24, 2019 | ATORVASTATIN | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 23, 2019 | VPI-ONDANSETRON ODT | Vpi Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| April 23, 2019 | SANDOZ GEFITINIB | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 23, 2019 | MAR-FEBUXOSTAT | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 23, 2019 | TEVA-FEBUXOSTAT | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| April 18, 2019 | DIFLUCAN ONE | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 18, 2019 | RIVA-LANSOPRAZOLE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 18, 2019 | NAPROXEN-NA; NAPROXEN-NA DF | Pro Doc Limitee | New Drug Submission (NDS) · Admin |
| April 18, 2019 | AG-OLANZAPINE FC; AG-OLANZAPINE ODT | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 18, 2019 | JARDIANCE | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| April 18, 2019 | TEVA-MEXILETINE | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 18, 2019 | REKOVELLE | Ferring Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 18, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 18, 2019 | TREMFYA ONE-PRESS | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2019 | FINASTERIDE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| April 17, 2019 | TOBRADEX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 17, 2019 | TRESIBA | Novo Nordisk Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 17, 2019 | SKYRIZI | AbbVie Corporation | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 15, 2019 | PREVNAR 13 | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 15, 2019 | ARSENIC TRIOXIDE SOLUTION FOR INJECTION | 10395579 Canada Inc (Phebra Canada Inc) | Abbreviated New Drug Submission (ANDS) · Other |
| April 15, 2019 | MIFEGYMISO | Linepharma International Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 15, 2019 | REBIF | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 12, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | Mda Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 12, 2019 | APRESOLINE | Sterimax Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 12, 2019 | MINT-ONDANSETRON ODT | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| April 11, 2019 | ESOMEPRAZOLE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 11, 2019 | PAMIDRONATE DISODIUM FOR INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 11, 2019 | APO-FENO-SUPER | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 11, 2019 | AIMOVIG | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 11, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 10, 2019 | PANTOPRAZOLE | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 10, 2019 | DICLOFENAC EC | Sanis Health Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| April 10, 2019 | MAR-PANTOPRAZOLE | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 10, 2019 | RAN-LANSOPRAZOLE | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 10, 2019 | LIBTAYO | Sanofi-Aventis Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 10, 2019 | PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 9, 2019 | MELOXADIN INJECTION | Norbrook Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| April 9, 2019 | A180 | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 9, 2019 | FORCERIS | Ceva Animal Health Inc | New Drug Submission (NDS) · Other |
| April 9, 2019 | OCREVUS | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2019 | TARO-MELPHALAN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 8, 2019 | 24 HOUR ALLERGY REMEDY | Vita Health Products Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 8, 2019 | ALOXI | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2019 | MELOXADIN ORAL SUSPENSION | Norbrook Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 8, 2019 | APO-TRANDOLAPRIL | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 5, 2019 | REACTINE ALLERGY | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | New Drug Submission (NDS) · Labelling Only |
| April 5, 2019 | ACT ANASTROZOLE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| April 5, 2019 | VERZENIO | Eli Lilly Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 5, 2019 | VANCOMYCIN INJECTION USP IN 0.9% SODIUM CHLORIDE; VANCOMYCIN INJECTION USP IN 5% DEXTROSE | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| April 5, 2019 | LOPERACAP | Valeant Canada Lp Valeant Canada S.E.C. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| April 4, 2019 | TRUXIMA | Celltrion Healthcare Co Ltd | New Drug Submission (NDS) · Other |
| April 4, 2019 | APO-HYDROXYUREA | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 4, 2019 | ROPIVACAINE HYDROCHLORIDE INJECTION USP | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 4, 2019 | FUNGIZONE | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| April 4, 2019 | TEVA-GABAPENTIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| April 4, 2019 | FORXIGA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 3, 2019 | ENGERIX-B | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 2, 2019 | DEXILANT | Takeda Canada Incorporated | Supplement to a New Drug Submission (SNDS) · Other |
| April 2, 2019 | CASPOFUNGIN FOR INJECTION | Fresenius Kabi Canada Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| April 2, 2019 | CELEBREX | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| April 2, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 2, 2019 | MVASI | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2019 | SPORANOX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2019 | ANANDRON | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 29, 2019 | ACH-FINGOLIMOD | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 29, 2019 | ACH-FINGOLIMOD | Accord Healthcare Inc | Abbreviated New Drug Submission (ANDS) · Other |
| March 29, 2019 | PROZINC | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2019 | OLANZAPINE ODT | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 29, 2019 | ALEMBIC-TELMISARTAN | Alembic Pharmaceuticals Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 29, 2019 | DENTICARE CHLORHEXIDINE GLUCONATE ORAL RINSE 0.12% | AMD Medicom Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 29, 2019 | NITRO-DUR 0.2; NITRO-DUR 0.4; NITRO-DUR 0.6; NITRO-DUR 0.8 | Uspharma Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 29, 2019 | VIVAXIM | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2019 | AVAXIM PEDIATRIC | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2019 | DIFICID | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2019 | XALKORI | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 28, 2019 | GALAFOLD | Amicus Therapeutics Uk Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| March 27, 2019 | M-PANTOPRAZOLE | Mantra Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 27, 2019 | CEFTRIAXONE SODIUM FOR INJECTION BP | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 27, 2019 | METOPROLOL | Sanis Health Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 27, 2019 | SANDOZ CEFPROZIL | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 27, 2019 | ALEVE NIGHTTIME | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 26, 2019 | GPC-ENTECAVIR | Generic Partners (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 26, 2019 | APO-LAMIVUDINE-ZIDOVUDINE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 25, 2019 | ENABLEX | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 25, 2019 | DIPROLENE | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 22, 2019 | FLUAD; FLUAD PEDIATRIC | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 22, 2019 | ENTUZITY KWIKPEN | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 21, 2019 | NRA-PANTOPRAZOLE | Nora Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 21, 2019 | METHOTREXATE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 21, 2019 | ACTEMRA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 21, 2019 | CIPROFLOXACIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 21, 2019 | SUNPHARMA ROSUVASTATIN | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 20, 2019 | ROCURONIUM BROMIDE INJECTION | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 20, 2019 | INLYTA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 20, 2019 | MINT-SILDENAFIL | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 20, 2019 | APO-AMOXI | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| March 20, 2019 | APO-OLMESARTAN/HCTZ | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| March 20, 2019 | PROLIA | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 20, 2019 | TRELEGY ELLIPTA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 20, 2019 | IMBRUVICA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 19, 2019 | EYLEA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 19, 2019 | MAR-DULOXETINE | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 18, 2019 | RIVASTIGMINE TRANSDERMAL PATCH | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 18, 2019 | REMIFENTANIL HYDROCHLORIDE FOR INJECTION | Sterimax Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 18, 2019 | VORICONAZOLE FOR INJECTION | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 15, 2019 | RAN-OMEPRAZOLE | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 15, 2019 | PANTOPRAZOLE | Altamed Pharma | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 15, 2019 | ACTONEL; ACTONEL DR | Allergan Inc | New Drug Submission (NDS) · Labelling Only |
| March 15, 2019 | APO-MYCOPHENOLATE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| March 15, 2019 | AMIKACIN SULFATE INJECTION | Omega Laboratories Limited | Abbreviated New Drug Submission (ANDS) · Other |
| March 15, 2019 | DIVIGEL | Searchlight Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 14, 2019 | KINEVAC | Bracco Imaging Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 14, 2019 | KUVAN | Biomarin International Limited | New Drug Submission (NDS) · Admin |
| March 14, 2019 | AURO-ATORVASTATIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 14, 2019 | ZIPRASIDONE CAPSULES | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 13, 2019 | AA-AMILZIDE | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| March 13, 2019 | HYPERRAB | Grifols Therapeutics Llc | Supplement to a New Drug Submission (SNDS) · Other |
| March 13, 2019 | GAMASTAN | Grifols Therapeutics Llc | Supplement to a New Drug Submission (SNDS) · Other |
| March 13, 2019 | JAMP-PIOGLITAZONE | JAMP Pharma Corporation | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| March 13, 2019 | ACT CITALOPRAM | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| March 13, 2019 | SANDOZ RABEPRAZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 13, 2019 | CALCITRIOL-ODAN | Odan Laboratories Ltd. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 13, 2019 | APIDRA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 13, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 12, 2019 | OSURNIA | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| March 12, 2019 | MODAFINIL TABLETS | Strides Pharma Canada Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 12, 2019 | RAMIPRIL | Altamed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| March 11, 2019 | SUDAFED SINUS ADVANCE | McNeil Consumer Healthcare, division of Johnson & Johnson Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 11, 2019 | MAR-FINGOLIMOD | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 11, 2019 | MAR-FINGOLIMOD | Marcan Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 11, 2019 | ENBREL | Immunex Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2019 | FEIBA NF | Shire Pharma Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2019 | PERIOGARD ALCOHOL FREE | Colgate-Palmolive Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 11, 2019 | APO-FINGOLIMOD | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 11, 2019 | XTORO | Merlion Pharmaceuticals Gmbh | New Drug Submission (NDS) · Labelling Only |
| March 11, 2019 | TEVA-FINGOLIMOD | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| March 11, 2019 | TARO-FINGOLIMOD | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| March 11, 2019 | MYLAN-FINGOLIMOD | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 11, 2019 | SANDOZ FINGOLIMOD | Sandoz Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| March 11, 2019 | TARO-FINGOLIMOD | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 11, 2019 | PMS-FINGOLIMOD | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 11, 2019 | MYLAN-FINGOLIMOD | Mylan Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Other |
| March 11, 2019 | RISEDRONATE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 11, 2019 | APO-FINGOLIMOD | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 11, 2019 | AZITHROMYCIN FOR INJECTION USP | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 11, 2019 | PMS-FINGOLIMOD | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 8, 2019 | FRAGMIN | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 8, 2019 | FLUTAMIDE | AA Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| March 8, 2019 | IPRATROPIUM BROMIDE AND SALBUTAMOL SULPHATE INHALATION SOLUTION | Mda Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 7, 2019 | DOXYCYCLINE CAPSULES; DOXYCYCLINE TABLETS | Sanis Health Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| March 7, 2019 | PIPERACILLIN AND TAZOBACTAM FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 6, 2019 | SANDOZ RAMIPRIL | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 6, 2019 | NIZORAL | Kramer Laboratories, Inc. | New Drug Submission (NDS) · Admin |
| March 6, 2019 | MINT-TELMISARTAN | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 6, 2019 | FUZEON | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| March 6, 2019 | OXALIPLATIN | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 6, 2019 | LUPRON; LUPRON DEPOT | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| March 6, 2019 | SANDOZ RAMIPRIL | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 5, 2019 | AURO-AMOXICILLIN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| March 5, 2019 | ONCASPAR | Servier Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 5, 2019 | APO-FULVESTRANT | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 5, 2019 | FOQUEST | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2019 | PRO-METFORMIN | Pro Doc Limitee | Supplement to a New Drug Submission (SNDS) · Admin |
| March 4, 2019 | RIVA-CLARITHROMYCIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 4, 2019 | ONGLYZA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2019 | KOMBOGLYZE | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2019 | DARZALEX | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 4, 2019 | APO-MOXIFLOXACIN | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| March 1, 2019 | FLONASE ALLERGY RELIEF | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 1, 2019 | ACT VENLAFAXINE XR | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| March 1, 2019 | NRA-QUETIAPINE | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 1, 2019 | MINESTRIN 1/20 | Allergan Inc | New Drug Submission (NDS) · Labelling Only |
| March 1, 2019 | NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP (21 DAY PACKAGE); NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP (28 DAY PACKAGE) | Glenmark Pharmaceuticals Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 1, 2019 | INFLUVAC TETRA | BGP Pharma ULC | New Drug Submission (NDS) · Other |
| February 28, 2019 | LORAZEPAM INJECTION USP | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 28, 2019 | TEVA-VARENICLINE | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| February 28, 2019 | JAMP NEVIRAPINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| February 28, 2019 | NRA-RAMIPRIL | Nora Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 28, 2019 | APO-MOMETASONE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 28, 2019 | CTP 30 | Sunovion Pharmaceuticals Canada Inc | Supplement to a New Drug Submission (SNDS) · Admin |
| February 28, 2019 | BYETTA | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 28, 2019 | ZOMETA CONCENTRATE | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2019 | ERELZI (PEN); ERELZI (SYRINGE) | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2019 | GPC-LINEZOLID | Generic Partners (Canada) Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 26, 2019 | TOPAGEN | Intervet Canada Corp | Supplement to a New Drug Submission (SNDS) · Other |
| February 26, 2019 | SUNPHARMA FENOFIBRATE E | Sun Pharma Canada Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| February 26, 2019 | VIZIMPRO | Pfizer Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| February 25, 2019 | RABAVERT | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | CERVARIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | INVIRASE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | FLUZONE HIGH-DOSE | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | FLUZONE QUADRIVALENT | Sanofi Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | MENJUGATE LIQUID | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | PERJETA; PERJETA - HERCEPTIN COMBO PACK | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | BEXSERO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | PEGASYS | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | MENVEO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 25, 2019 | ORAP | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 22, 2019 | LORBRENA | Pfizer Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| February 22, 2019 | APO-AMIODARONE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 22, 2019 | REXULTI | Otsuka Pharmaceutical Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| February 22, 2019 | NASACORT ALLERGY 24HR | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 21, 2019 | CUBICIN; CUBICIN RF | Cubist Pharmaceuticals Llc | Supplement to a New Drug Submission (SNDS) · Other |
| February 21, 2019 | SANDOZ LANSOPRAZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 21, 2019 | MINT-ENTECAVIR | Mint Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 21, 2019 | JAMP ENTECAVIR | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| February 21, 2019 | AURO-ALENDRONATE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 20, 2019 | TOBREX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 20, 2019 | EVICEL | Omrix Biopharmaceuticals Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| February 20, 2019 | GEMCITABINE INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 20, 2019 | APO-AMPHETAMINE XR | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 20, 2019 | M-ESLON | Ethypharm Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 19, 2019 | KYE-ESCITALOPRAM | Kye Pharmaceuticals Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| February 19, 2019 | SANDOZ OMEPRAZOLE | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 19, 2019 | APO-CLONAZEPAM | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 19, 2019 | VOLTAREN; VOLTAREN SR | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 19, 2019 | FLOLAN; PH 12 STERILE DILUENT FOR FLOLAN | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 18, 2019 | ACT METFORMIN | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| February 18, 2019 | VENCLEXTA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| February 15, 2019 | ENVARSUS PA | Endo Ventures Ltd | New Drug Submission (NDS) · Other |
| February 15, 2019 | APO-AMITRIPTYLINE | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 15, 2019 | PANTOPRAZOLE FOR INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 15, 2019 | ULTRA TECHNEKOW V4 | Curium Canada Inc | New Drug Submission (NDS) · Admin |
| February 15, 2019 | ATORVASTATIN-10; ATORVASTATIN-20; ATORVASTATIN-40; ATORVASTATIN-80 | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 14, 2019 | NAT-LETROZOLE | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 14, 2019 | TADALAFIL | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 13, 2019 | YESCARTA | Gilead Sciences Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| February 12, 2019 | TARO-CALCITRIOL | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 12, 2019 | ACID REDUCER | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 12, 2019 | PRIVA-SIMVASTATIN | Pharmapar Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 12, 2019 | SIMPONI I.V. | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2019 | DICLOFENAC SODIUM SOLUTION | Teligent Pharma, Inc . | Abbreviated New Drug Submission (ANDS) · Admin |
| February 12, 2019 | GLYBURIDE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| February 12, 2019 | LOXICOM ORAL SUSPENSION | Norbrook Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| February 12, 2019 | HEMLIBRA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2019 | AG-DUTASTERIDE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 12, 2019 | PULMOZYME | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 12, 2019 | FLURBIPROFEN | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| February 11, 2019 | CYSTADROPS | Recordati Rare Diseases Canada Inc | New Drug Submission (NDS) · Priority |
| February 11, 2019 | IMBRUVICA | Janssen Inc. | Supplement to a New Drug Submission (SNDS) · Priority |
| February 11, 2019 | ERELZI (PREFILLED SYRINGE) | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2019 | TORADOL IM | Atnahs Pharma Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 11, 2019 | AVELOX; AVELOX I.V. | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 11, 2019 | LEVOFLOXACIN IN 5% DEXTROSE INJECTION | Pfizer Canada Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 11, 2019 | ENABLEX | Searchlight Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| February 11, 2019 | FUROSEMIDE INJECTION USP | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 8, 2019 | OXERVATE | Dompé Farmaceutici S.P.A. | New Drug Submission (NDS) · Priority-NAS |
| February 8, 2019 | AURO-CANDESARTAN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 8, 2019 | CIMZIA | Ucb Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 7, 2019 | RENVELA | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 7, 2019 | PRADAXA | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| February 7, 2019 | HYDROMORPHONE HYDROCHLORIDE INJECTION USP | Sterinova Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 6, 2019 | IDHIFA | Celgene Inc | New Drug Submission (NDS) · Priority-NAS |
| February 5, 2019 | FENTANYL PATCH | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 5, 2019 | DEXIRON | American Regent, Inc | New Drug Submission (NDS) · Admin |
| February 5, 2019 | QUINSAIR | Horizon Pharma Ireland Ltd | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 5, 2019 | TECFIDERA | Biogen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 5, 2019 | BACLOFEN INTRATHECAL | Avir Pharma Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 5, 2019 | LABETALOL HYDROCHLORIDE INJECTION USP | Sandoz Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 4, 2019 | RAN-CEFPROZIL | Ranbaxy Pharmaceuticals Canada Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| February 4, 2019 | XELJANZ | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 4, 2019 | ADVIL MINI-GELS | Pfizer Consumer Healthcare, a division of Pfizer Canada ULC | Supplement to a New Drug Submission (SNDS) · Other |
| February 4, 2019 | CLINDAMYCIN INJECTION IN 5% DEXTROSE | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| February 4, 2019 | REVOLADE | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 4, 2019 | ROCALTROL | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 4, 2019 | STIVARGA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 4, 2019 | AG-CYCLOBENZAPRINE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 1, 2019 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| February 1, 2019 | CIPRO; CIPRO ORAL SUSPENSION | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 1, 2019 | JAMP RIVASTIGMINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| February 1, 2019 | CIPRO XL | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| February 1, 2019 | TOLAK | Hill Dermaceuticals, Inc. | New Drug Submission (NDS) · Other |
| January 31, 2019 | DOMIDINE | Eurovet Animal Health B V | Abbreviated New Drug Submission (ANDS) · Other |
| January 31, 2019 | QUEST PLUS GEL | Zoetis Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 31, 2019 | ROSUVASTATIN | Sivem Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 31, 2019 | APO-CANDESARTAN | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 31, 2019 | TEVA-LATANOPROST | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| January 31, 2019 | APO-DEFERASIROX (TYPE J) | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 31, 2019 | BORTEZOMIB FOR INJECTION | Mda Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 30, 2019 | ELTROXIN | Aspen Pharmacare Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 30, 2019 | XELJANZ; XELJANZ XR | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 30, 2019 | AG-LEVETIRACETAM | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 29, 2019 | STRENSIQ | Alexion Pharma Gmbh | Supplement to a New Drug Submission (SNDS) · Other |
| January 28, 2019 | AG-ALENDRONATE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 28, 2019 | APO-PERINDOPRIL | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| January 25, 2019 | EXTRA STRENGTH ALLERGY RELIEF | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 25, 2019 | ONCASPAR | Servier Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| January 25, 2019 | KALYDECO | Vertex Pharmaceuticals (Canada) Incorporated | Supplement to a New Drug Submission (SNDS) · Priority |
| January 25, 2019 | OVUGEL | Vetoquinol N A Inc | New Drug Submission (NDS) · Admin |
| January 25, 2019 | SYNOVEX LA-F | Zoetis Canada Inc | New Drug Submission (NDS) · Other |
| January 25, 2019 | SYNOVEX LA-G | Zoetis Canada Inc | New Drug Submission (NDS) · Other |
| January 24, 2019 | PANTOPRAZOLE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 24, 2019 | BARACLUDE | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 24, 2019 | VIIBRYD | Allergan Inc | New Drug Submission (NDS) · Labelling Only |
| January 24, 2019 | APTIOM | Sunovion Pharmaceuticals Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 24, 2019 | AG-CLINDAMYCIN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 24, 2019 | VENOFER | American Regent, Inc | New Drug Submission (NDS) · Admin |
| January 24, 2019 | PEMETREXED DISODIUM FOR INJECTION USP | Marcan Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 24, 2019 | TEVA-DICLOFENAC EC; TEVA-DICLOFENAC SR | Teva Canada Limited | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 23, 2019 | JAMP-LATANOPROST/TIMOLOL | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| January 23, 2019 | JAMP-DORZOLAMIDE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| January 23, 2019 | HUMIRA | AbbVie Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| January 23, 2019 | OPDIVO | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2019 | CIPROFLOXACIN INTRAVENOUS INFUSION, BP | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 22, 2019 | SUBOXONE | Indivior Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2019 | AGRIFLU | Seqirus Uk Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 22, 2019 | METFORMIN | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 22, 2019 | MINT-PANTOPRAZOLE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 22, 2019 | BAR-METHYLPHENIDATE HCL CR | Bard Pharmaceuticals (1990) Inc | New Drug Submission (NDS) · Admin |
| January 22, 2019 | AG-FLUOXETINE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 22, 2019 | CIMETIDINE | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| January 22, 2019 | JAMP DUTASTERIDE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| January 22, 2019 | OVIDREL | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 22, 2019 | JAMP CINACALCET | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| January 21, 2019 | VANCOCIN | Searchlight Pharma Inc. | New Drug Submission (NDS) · Admin |
| January 21, 2019 | SYNFLORIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 21, 2019 | DEMYLOCAN | Pendopharm Division Of Pharmascience Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| January 18, 2019 | SULFATRIM; SULFATRIM DS; SULFATRIM PEDIATRIC | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| January 18, 2019 | ROSIGLITAZONE | AA Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| January 18, 2019 | ESBRIET | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 18, 2019 | KYPROLIS | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 18, 2019 | TRANEXAMIC ACID INJECTION | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 17, 2019 | CIPRODEX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 17, 2019 | MVASI | Amgen Canada Inc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 17, 2019 | FLUCONAZOLE-150 | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 17, 2019 | AG-MOXIFLOXACIN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 17, 2019 | MINT-ANASTROZOLE | Mint Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 17, 2019 | AG-CANDESARTAN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 17, 2019 | JAMP DORZOLAMIDE-TIMOLOL | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| January 17, 2019 | APRESOLINE | Sterimax Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2019 | ERELZI | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 17, 2019 | MESNA FOR INJECTION | Fresenius Kabi Canada Ltd | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 17, 2019 | TIGECYCLINE FOR INJECTION | Neo Health Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 16, 2019 | PMS-FENTANYL MTX | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 16, 2019 | RAMIPRIL | Sivem Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 16, 2019 | RISEDRONATE | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 16, 2019 | OLANZAPINE | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 15, 2019 | HALAVEN | Eisai Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2019 | KEYTRUDA | Merck Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2019 | EYLEA | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2019 | AURO-PAROXETINE | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 15, 2019 | BACLOFEN-10; BACLOFEN-20 | Pro Doc Limitee | New Drug Submission (NDS) · Admin |
| January 15, 2019 | LOESTRIN 1.5/30 | Allergan Inc | New Drug Submission (NDS) · Labelling Only |
| January 15, 2019 | FULVESTRANT INJECTION | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 15, 2019 | FULVESTRANT INJECTION | Mylan Pharmaceuticals Ulc | Abbreviated New Drug Submission (ANDS) · Other |
| January 15, 2019 | TEVA-FULVESTRANT INJECTION | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 15, 2019 | FULVESTRANT INJECTION | Sandoz Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 15, 2019 | FULVESTRANT INJECTION | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Labelling Only |
| January 15, 2019 | TEVA-FULVESTRANT INJECTION | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2019 | SANDOZ PERINDOPRIL ERBUMINE/INDAPAMIDE HD | Sandoz Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 14, 2019 | PATADAY | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 14, 2019 | RUMENSIN PREMIX | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 14, 2019 | COBAN PREMIX | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 14, 2019 | SEROSTIM | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 14, 2019 | LUVERIS | Emd Serono A Division Of Emd Inc Canada | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 11, 2019 | PDP-AMLODIPINE | Pendopharm Division Of Pharmascience Inc | New Drug Submission (NDS) · Other |
| January 11, 2019 | LISINOPRIL/HCTZ (TYPE Z) | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 11, 2019 | AG-RISPERIDONE | Angita Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 11, 2019 | VOLTAREN RAPIDE | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2019 | ZOLADEX; ZOLADEX LA | Tersera Therapeutics Llc | Supplement to a New Drug Submission (SNDS) · Labelling Only |
| January 10, 2019 | DUTASTERIDE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP | Teligent Pharma, Inc . | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | AG-VARDENAFIL | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | AG TELMISARTAN-HCT | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | JAMP LATANOPROST | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | AG-OMEPRAZOLE DR | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | ONSTRYV | Valeo Pharma Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| January 10, 2019 | ACT OLANZAPINE ODT | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | DIAZEPAM | AA Pharma Inc. | New Drug Submission (NDS) · Labelling Only |
| January 10, 2019 | APO-MONTELUKAST | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| January 10, 2019 | AG-TELMISARTAN | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 10, 2019 | MOZOBIL | Sanofi-Aventis Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 10, 2019 | VONVENDI | Shire Pharma Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| January 9, 2019 | BREO ELLIPTA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 9, 2019 | LUTATHERA | Advanced Accelerator Applications Usa, Inc. | New Drug Submission (NDS) · Priority-NAS |
| January 9, 2019 | JINARC | Otsuka Pharmaceutical Co Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| January 8, 2019 | GALLIPRANT | Elanco Canada Limited | New Drug Submission (NDS) · Other |
| January 7, 2019 | AG-RANITIDINE | Angita Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 7, 2019 | BIO-SIMVASTATIN | Biomed Pharma | Abbreviated New Drug Submission (ANDS) · Admin |
| January 7, 2019 | APO-LEVOCARB CR | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 7, 2019 | MYLAN-LANSOPRAZOLE | Mylan Pharmaceuticals Ulc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 7, 2019 | MIRAPEX | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| January 4, 2019 | ONIVYDE | Servier Canada Inc. | New Drug Submission (NDS) · Labelling Only |
| January 4, 2019 | BEXSERO | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 4, 2019 | RECOTHROM | Baxter Corporation | New Drug Submission (NDS) · Admin |
| January 3, 2019 | QUETIAPINE TABLETS | Accord Healthcare Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 3, 2019 | NIX DERMAL CREAM | Glaxosmithkline Consumer Healthcare Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 3, 2019 | XELODA | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 3, 2019 | TARO-OXALIPLATIN | Taro Pharmaceuticals Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 3, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Mda Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 3, 2019 | LACOSAMIDE | Jubilant Generics Limited | Abbreviated New Drug Submission (ANDS) · Other |
| January 3, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Accord Healthcare Inc | Abbreviated New Drug Submission (ANDS) · Other |
| January 3, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Mda Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 3, 2019 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 3, 2019 | AURO-TELMISARTAN | Auro Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 3, 2019 | TEVA-ARSENIC TRIOXIDE FOR INJECTION | Teva Canada Limited | New Drug Submission (NDS) · Admin |
| January 3, 2019 | NAT-GRANISETRON | Natco Pharma (Canada) Inc | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 3, 2019 | MILBEMAX | Elanco Canada Limited | Supplement to a New Drug Submission (SNDS) · Other |
| January 3, 2019 | V-MAX 44 | Phibro Animal Health Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| January 3, 2019 | V-MAX 500 | Phibro Animal Health Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| January 2, 2019 | MISOPROSTOL | AA Pharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 2, 2019 | TEVA-LEVOFLOXACIN | Teva Canada Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 2, 2019 | NORFLOXACIN | AA Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 2, 2019 | AMLODIPINE | Jubilant Generics Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| January 2, 2019 | RAMIPRIL | Sanis Health Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 2, 2019 | ONDANSETRON | Pro Doc Limitee | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| January 2, 2019 | APO-AMOXI CLAV | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Labelling Only |
| January 2, 2019 | JAMP-CYCLOBENZAPRINE | JAMP Pharma Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| January 2, 2019 | AURO-QUINAPRIL HCTZ | Auro Pharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 2, 2019 | TEVA-QUINAPRIL/HCTZ | Teva Canada Limited | Abbreviated New Drug Submission (ANDS) · Other |