Notices of Compliance, 2004
636 notices issued in 2004, newest first.
| Date | Products | Company | Submission |
|---|---|---|---|
| December 29, 2004 | ALDARA 5% CREAM | 3M Pharmaceuticals, A Division Of 3M Canada Company | Supplement to a New Drug Submission (SNDS) · Other |
| December 29, 2004 | GLEEVEC | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 29, 2004 | XATRAL | Sanofi-Synthelabo Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 24, 2004 | CLARITIN ALLERGY + SINUS EXTRA STRENGTH | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 24, 2004 | CLARITIN ALLERGY + SINUS | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 24, 2004 | STRATTERA | Eli Lilly Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 24, 2004 | SUPRAX | Aventis Pharma Inc. | New Drug Submission (NDS) · Admin |
| December 24, 2004 | RIVA-TERBINAFINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 24, 2004 | HYDROMORPH.IR | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Admin |
| December 24, 2004 | EFUDEX | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| December 24, 2004 | CO BUSPIRONE | Cobalt Pharmaceuticals Incorporated | New Drug Submission (NDS) · Admin |
| December 24, 2004 | CIPRALEX | Lundbeck Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 23, 2004 | VAQTA | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| December 22, 2004 | KETEK | Aventis Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 21, 2004 | ANGIOMAX | Oryx Pharmaceuticals Inc., A Subsidiary Of Filiale D'arrow Pharmaceuticals Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 21, 2004 | GEN-FOSINOPRIL | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 21, 2004 | ZYPREXA INTRAMUSCULAR | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 17, 2004 | RHOXAL-ESTRADIOL DERM | Rhoxalpharma Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| December 17, 2004 | XENICAL | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Priority |
| December 16, 2004 | AVONEX | Biogen Idec Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| December 16, 2004 | OVIDREL | Serono Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 16, 2004 | PUREGON (SOLUTION FOR INJECTION); PUREGON (SOLUTION FOR INJECTION IN CARTRIDGES) | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 16, 2004 | PHL-AMANTADINE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| December 16, 2004 | PHL-AMANTADINE SYRUP | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| December 16, 2004 | PHL-FLUVOXAMINE | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 16, 2004 | PHL-IPRATROPIUM | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| December 14, 2004 | HEMOFIL M INJ | Baxter Healthcare Corporation | New Drug Submission (NDS) · Admin |
| December 14, 2004 | RECOMBINATE | Baxter Healthcare Corporation | New Drug Submission (NDS) · Admin |
| December 13, 2004 | ANDRODERM | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 13, 2004 | PHL-DESIPRAMINE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| December 13, 2004 | PHL-LITHIUM CARBONATE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| December 13, 2004 | PHL-TRYPTOPHAN | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| December 13, 2004 | PHL-TRYPTOPHAN | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| December 13, 2004 | PROPOFOL INJECTION | Hospira Healthcare Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| December 10, 2004 | EFFEXOR XR | Wyeth Canada | Supplement to a New Drug Submission (SNDS) · Other |
| December 10, 2004 | MYOCET | Sopherion Therapeutics, Inc. | New Drug Submission (NDS) · Admin |
| December 10, 2004 | NOVO-LEFLUNOMIDE | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| December 10, 2004 | SANDOZ-TERBINAFINE | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 10, 2004 | TELZIR | Glaxosmithkline Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 10, 2004 | YASMIN 21; YASMIN 28 | Berlex Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 9, 2004 | NOVO-METOPROL | Novopharm Limited | Supplement to a New Drug Submission (SNDS) · Other |
| December 8, 2004 | CANCIDAS | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| December 8, 2004 | EBIXA | Lundbeck Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| December 8, 2004 | FLUCONAZOLE INJECTION | Baxter Corporation | Abbreviated New Drug Submission (ANDS) · Other |
| December 8, 2004 | TOBREXAN | Alcon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 6, 2004 | HUMATE-P | Aventis Behring Llc | Supplement to a New Drug Submission (SNDS) · Other |
| December 6, 2004 | HABITROL | Novartis Consumer Health Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 3, 2004 | SANDOZ-DICLOFENAC; SANDOZ-DICLOFENAC SR | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 3, 2004 | RATIO-OMEPRAZOLE | Ratiopharm Inc. | New Drug Submission (NDS) · Admin |
| December 3, 2004 | HEPSERA | Gilead Sciences, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| December 2, 2004 | YTTRIUM-90 CHLORIDE STERILE SOLUTION | Mds Nordion, A Division Of Mds (Canada) Inc. | New Drug Submission (NDS) · Priority-NAS |
| December 2, 2004 | PMS-FOSINOPRIL | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| December 1, 2004 | ADVIL PEDIATRIC DROPS; CHILDREN'S ADVIL SUSPENSION | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| December 1, 2004 | SANDOZ-PINDOLOL | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 1, 2004 | SANDOZ-DICLOFENAC RAPIDE | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 1, 2004 | SANDOZ-CARBAMAZEPINE CHEWTABS; SANDOZ-CARBAMAZEPINE CR | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 1, 2004 | SANDOZ-CALCITONIN NS | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 1, 2004 | DEFEROXAMINE MESYLATE FOR INJECTION | Sandoz Inc. | New Drug Submission (NDS) · Admin |
| December 1, 2004 | CLASTEON | Oryx Pharmaceuticals Inc., A Subsidiary Of Filiale D'arrow Pharmaceuticals Inc. | New Drug Submission (NDS) · Admin |
| November 30, 2004 | GAMMAGARD S/D | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| November 30, 2004 | PREVACID IV | Tap Pharmaceuticals, Inc. | New Drug Submission (NDS) · Other |
| November 30, 2004 | PREVACID | Tap Pharmaceuticals, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 29, 2004 | CERETEC | Amersham Health Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 29, 2004 | RATIO-SOTALOL | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 29, 2004 | PHL-SALBUTAMOL RESPIRATOR SOLUTION | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 29, 2004 | PHL-SALBUTAMOL RESPIRATOR SOLUTION | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 29, 2004 | NOVO-LEVOFLOXACIN | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| November 29, 2004 | CROWN-TIM | Allergan Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| November 26, 2004 | STARLIX | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2004 | SALIX (FUROSEMIDE INJECTION 5% STERILE SOLUTION) | Intervet Canada Corp | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2004 | UNITRON PEG | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2004 | PEGETRON | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2004 | METASTRON | Amersham Health Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 26, 2004 | INDIUM IN-111 CHLORIDE STERILE SOLUTION | Amersham Health Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 25, 2004 | FUNGIZONE | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| November 25, 2004 | APO-BRIMONIDINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 24, 2004 | A 180 (DANOFLOXACIN MESYLATE STERILE INJECTABLE SOLUTION) | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| November 23, 2004 | PHL-SALBUTAMOL ORAL LIQUID | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 23, 2004 | KENALOG IN ORABASE | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| November 23, 2004 | NICOTROL | Pfizer Canada Inc., Consumer Healthcare Division | New Drug Submission (NDS) · Admin |
| November 23, 2004 | NICODERM | Pfizer Canada Inc., Consumer Healthcare Division | New Drug Submission (NDS) · Admin |
| November 23, 2004 | SAIZEN | Serono Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 18, 2004 | XOLAIR | Novartis Pharmaceuticals Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| November 17, 2004 | ZORCAINE | Kodak Canada Inc. | New Drug Submission (NDS) · Admin |
| November 17, 2004 | RELEFACT | Odan Laboratories Ltd. | New Drug Submission (NDS) · Admin |
| November 17, 2004 | RATIO-GABAPENTIN | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 17, 2004 | PHL-VALPROIC ACID E.C. | Pharmel Inc. | New Drug Submission (NDS) · Admin |
| November 17, 2004 | PHL-VALPROIC ACID | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| November 17, 2004 | PHL-RANITIDINE | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 17, 2004 | PHL-OXYBUTYNIN | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 17, 2004 | PHL-NIZATIDINE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 17, 2004 | FROVA | Endo Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| November 17, 2004 | FRISIUM | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| November 17, 2004 | ECOSTATIN | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| November 15, 2004 | TETANUS TOXOID ADSORBED | Id Biomedical Corporation | New Drug Submission (NDS) · Admin |
| November 14, 2004 | ROVAMYCINE | Odan Laboratories Ltd. | New Drug Submission (NDS) · Admin |
| November 10, 2004 | APO-TIZANIDINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| November 8, 2004 | PHL-VALPROIC ACID | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 8, 2004 | PHL-CLONAZEPAM-R | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 8, 2004 | DESYREL; DESYREL DIVIDOSE | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| November 8, 2004 | CYTOXAN | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| November 8, 2004 | BUSPAR | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| November 8, 2004 | ENTROPHEN TABLET; ENTROPHEN CAPLET | Pendopharm Inc. | New Drug Submission (NDS) · Admin |
| November 5, 2004 | SEROQUEL | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| November 5, 2004 | MICOTIL (TILMICOSIN INJECTION) | Elanco, Division Of Eli Lilly Canada Inc. | New Drug Submission (NDS) · Other |
| November 2, 2004 | MYOVIEW | Amersham Health Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| November 2, 2004 | OXYMYCINE LA (STERILE INJECTABLE SOLUTION) | Wyeth Animal Health, Division Of Wyeth Canada | New Drug Submission (NDS) · Other |
| November 2, 2004 | CALICIDE | Skretting | New Drug Submission (NDS) · Other |
| November 1, 2004 | ZADITEN | Pendopharm Inc. | New Drug Submission (NDS) · Admin |
| November 1, 2004 | RIVA-GABAPENTIN | Laboratoire Riva Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| November 1, 2004 | PHL-IPRATROPIUM; PHL-IPRATROPIUM - 20ML BOTTLE; PHL-IPRATROPIUM - 1ML UNIT DOSE; PHL-IPRATROPIUM - 2ML UNIT DOSE | Pharmel Inc. | New Drug Submission (NDS) · Admin |
| November 1, 2004 | PHL-CHOLESTYRAMINE LIGHT; PHL-CHOLESTYRAMINE LIGHT 210G TIN; PHL-CHOLESTYRAMINE REGULAR; PHL-CHOLESTYRAMINE REGULAR 378G TIN | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 1, 2004 | PHL-CHOLESTYRAMINE POWDER 210G/CAN; PHL-CHOLESTYRAMINE LIGHT POWDER; PHL-CHOLESTYRAMINE POWDER FOR SUSPENSION 400GM/CAN | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| November 1, 2004 | RHOXAL-LOPERAMIDE | Rhoxalpharma Inc. | New Drug Submission (NDS) · Admin |
| November 1, 2004 | ANAFEN (KETOPROFEN INJECTION) | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| October 28, 2004 | CAPOTEN | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | CORGARD | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | DURICEF | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | HYDREA | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | LYSODREN | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | PARAPLATIN-AQ | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | RHOXAL-ANAGRELIDE | Rhoxalpharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 28, 2004 | SANDOMIGRAN; SANDOMIGRAN DS | Pendopharm Inc. | New Drug Submission (NDS) · Admin |
| October 28, 2004 | VUMON | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| October 28, 2004 | SAIZEN | Serono Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 28, 2004 | SEROSTIM | Serono Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 22, 2004 | APO-METHIMAZOLE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| October 22, 2004 | DITROPAN XL | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 22, 2004 | NOVO-MIRTAZAPINE | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| October 21, 2004 | AVANDARYL | Glaxosmithkline Inc | New Drug Submission (NDS) · Other |
| October 20, 2004 | ZYPREXA; ZYPREXA ZYDIS; ZYPREXA INTRAMUSCULAR | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| October 20, 2004 | ARIXTRA | Glaxosmithkline Inc | New Drug Submission (NDS) · Admin |
| October 20, 2004 | SABRIL | Ovation Pharmaceuticals, Incorporated | New Drug Submission (NDS) · Admin |
| October 19, 2004 | FORTEKOR 5 MG TABLETS | Novartis Animal Health Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 18, 2004 | KIDROLASE | Opi S.A. | New Drug Submission (NDS) · Admin |
| October 13, 2004 | RATIO-TRYPTOPHAN | Ratiopharm Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| October 13, 2004 | TRYPTAN | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| October 12, 2004 | GALLIMYCIN-200 (USP STERILE ERYTHROMYCIN INJECTION) | Vetoquinol N A Inc | New Drug Submission (NDS) · Other |
| October 12, 2004 | NEISVAC-C | Id Biomedical Corporation | New Drug Submission (NDS) · Admin |
| October 12, 2004 | PACIS | Id Biomedical Corporation | New Drug Submission (NDS) · Admin |
| October 12, 2004 | BCI CAPTOPRIL TABLETS | Baker Cummins Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | BCI SALBUTAMOL INHALATION SOLUTION | Baker Cummins Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | CARBOLITH | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| October 12, 2004 | CO CAPTOPRIL | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | CO CEFACLOR | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | CO CEFACLOR SUSPENSION | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | CO FAMOTIDINE | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | CO MINOCYCLINE | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | CO SALBUTAMOL INHALATION SOLUTION | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| October 12, 2004 | ETIBI | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| October 12, 2004 | MESTINON-SR | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| October 12, 2004 | OXSORALEN; OXSORALEN LOTION; OXSORALEN ULTRA | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| October 12, 2004 | SINTROM | Pendopharm Inc. | New Drug Submission (NDS) · Admin |
| October 12, 2004 | TRI-CYCLEN LO (21 DAY); TRI-CYCLEN LO (28 DAY) | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2004 | COZAAR | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2004 | EDECRIN | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| October 7, 2004 | FRAGMIN | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Priority |
| October 7, 2004 | HYZAAR; HYZAAR DS | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| October 6, 2004 | RIVA-PRAVASTATIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| October 6, 2004 | ZOMETA | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| October 6, 2004 | AMEVIVE | Biogen Idec Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| October 5, 2004 | LIPITOR | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| October 1, 2004 | COSOPT | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| September 30, 2004 | ARICEPT | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| September 28, 2004 | LIBRAX | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 24, 2004 | HUMIRA | Abbott Laboratories Co. | New Drug Submission (NDS) · New Active Substance (NAS) |
| September 23, 2004 | DIARRHEA RELIEF | Vita Health Products Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| September 23, 2004 | ARIXTRA | Organon Sanofi-Synthelabo Canada | Supplement to a New Drug Submission (SNDS) · Other |
| September 23, 2004 | DESMOPRESSIN NASAL SPRAY | Rainbow Pharmaceuticals Inc | Supplement to a New Drug Submission (SNDS) · Admin |
| September 23, 2004 | FRAXIPARINE; FRAXIPARINE FORTE | Glaxosmithkline Inc | New Drug Submission (NDS) · Admin |
| September 23, 2004 | MOGADON | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 23, 2004 | OXYCONTIN | Purdue Pharma | Supplement to a New Drug Submission (SNDS) · Other |
| September 22, 2004 | SPUTOLYSIN POWDER | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| September 21, 2004 | HUMALOG | Eli Lilly Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| September 21, 2004 | CESAMET | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 21, 2004 | FACTIVE | Oscient Pharmaceutical Corporation | New Drug Submission (NDS) · Admin |
| September 21, 2004 | GLYCON | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 21, 2004 | NITRAZADON | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 21, 2004 | OXYBUTYN | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 21, 2004 | VIRACEPT | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| September 17, 2004 | NOVO-MELOXICAM | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| September 17, 2004 | PREVORA STAGE 1 | Chx Technologies Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 17, 2004 | TRASYLOL | Bayer Inc. | New Drug Submission (NDS) · Admin |
| September 16, 2004 | ZOCLONE | Prempharm Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| September 15, 2004 | RHOXAL-PAROXETINE | Rhoxalpharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| September 14, 2004 | ROFACT | Valeant Canada Lp | New Drug Submission (NDS) · Admin |
| September 13, 2004 | DOM-GABAPENTIN | Dominion Pharmacal | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| September 13, 2004 | EFFEXOR XR | Wyeth Canada | Supplement to a New Drug Submission (SNDS) · Other |
| September 13, 2004 | GEN-CLINDAMYCIN | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 13, 2004 | SUSTIVA | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| September 13, 2004 | VIRAMUNE | Boehringer Ingelheim (Canada) Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| September 13, 2004 | NUFLOR (STERILE INJECTABLE SOLUTION ANTIBIOTIC) | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| September 10, 2004 | MAXIPIME | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| September 9, 2004 | KETAMINE HYDROCHLORIDE INJECTION USP | Sabex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 8, 2004 | CELEBREX | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| September 8, 2004 | APO-LEFLUNOMIDE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| September 3, 2004 | THYMOGLOBULIN | Genzyme Canada Inc | New Drug Submission (NDS) · Admin |
| September 3, 2004 | FROVA | Vernalis Development Limited | New Drug Submission (NDS) · New Active Substance (NAS) |
| September 2, 2004 | REMERON RD | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 31, 2004 | TYLAN SOLUBLE | Elanco, Division Of Eli Lilly Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 31, 2004 | BIO-COX 120 G-PLUS | Alpharma Canada Corporation | New Drug Submission (NDS) · Other |
| August 31, 2004 | MITABAN LIQUID CONCENTRATE | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| August 31, 2004 | IBUPROFEN 200 MG | Pharmetics Inc | New Drug Submission (NDS) · Admin |
| August 31, 2004 | PHL-GABAPENTIN | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| August 30, 2004 | ZYMAR | Allergan Inc | New Drug Submission (NDS) · Other |
| August 27, 2004 | VINORELBINE TARTRATE FOR INJECTION | Mayne Pharma (Canada) Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 24, 2004 | RHOXAL-SOTALOL | Rhoxalpharma Inc. | New Drug Submission (NDS) · Admin |
| August 24, 2004 | RENAGEL | Genzyme Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 24, 2004 | CO METFORMIN | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| August 23, 2004 | RITUXAN | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 23, 2004 | INDIUM 111-IN OXINE SOLUTION | Amersham Health Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 20, 2004 | VFEND | Pfizer Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 20, 2004 | DESMOPRESSIN TABLETS | Rainbow Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| August 19, 2004 | CYCLESSA | Organon Canada Inc. | New Drug Submission (NDS) · Other |
| August 19, 2004 | AMCORT | Taropharma, A Division Of Taro Pharmaceuticals Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| August 19, 2004 | MYOBLOC | Solstice Neurosciences, Llc | New Drug Submission (NDS) · Admin |
| August 18, 2004 | GEN-PRAVASTATIN | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 17, 2004 | RHOXAL-ZOPICLONE | Rhoxalpharma Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 17, 2004 | RHOXAL-ACEBUTOLOL | Rhoxalpharma Inc. | New Drug Submission (NDS) · Admin |
| August 17, 2004 | BCI FAMOTIDINE | Baker Cummins Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| August 17, 2004 | BCI ATENOLOL | Baker Cummins Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| August 16, 2004 | GEN-MIRTAZAPINE | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 16, 2004 | TWINRIX ADULT; TWINRIX JR | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 16, 2004 | HAVRIX 1440; HAVRIX 720 JR. | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 13, 2004 | AMILORIDE HYDROCHLORIDE TABLETS, USP | Orbus Pharma Inc. | New Drug Submission (NDS) · Admin |
| August 13, 2004 | AVALIDE | Sanofi-Synthelabo Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 13, 2004 | BCI FLUVOXAMINE TABLETS | Baker Cummins Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| August 13, 2004 | CITALOPRAM-20; CITALOPRAM-40 | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| August 13, 2004 | CO GABAPENTIN | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| August 13, 2004 | GEN-DILTIAZEM CD | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| August 13, 2004 | HYDROCHLOROTHIAZIDE AND AMILORIDE HYDROCHLORIDE TABLETS USP | Orbus Pharma Inc. | New Drug Submission (NDS) · Admin |
| August 13, 2004 | RHODACINE | Rhoxalpharma Inc. | New Drug Submission (NDS) · Admin |
| August 13, 2004 | TRILEPTAL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 12, 2004 | TIAZAC XC | Biovail Pharmaceuticals Canada Division Of Biovail Corporation | New Drug Submission (NDS) · Other |
| August 10, 2004 | PUREGON | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 10, 2004 | REMICADE | Centocor Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 10, 2004 | GEN-MELOXICAM | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| August 9, 2004 | BOOSTRIX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| August 9, 2004 | IMOVAX POLIO | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| August 9, 2004 | INFANRIX-IPV/HIB | Glaxosmithkline Inc | New Drug Submission (NDS) · Other |
| August 9, 2004 | SENSIPAR | Amgen Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| August 5, 2004 | RELPAX | Pfizer Canada Ulc | New Drug Submission (NDS) · New Active Substance (NAS) |
| August 5, 2004 | TEVETEN | Solvay Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| August 5, 2004 | ASPIRIN 81MG | Bayer Inc., Consumer Care Division | Supplement to a New Drug Submission (SNDS) · Other |
| August 4, 2004 | RANITIDINE INJECTION USP | Sabex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 30, 2004 | PNEUMOVAX 23 (SINGLE DOSE); PNEUMOVAX 23 (MULTI DOSE) | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| July 30, 2004 | APO-BISOPROLOL | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| July 29, 2004 | RAPINOVET INJECTION | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2004 | CESAMET | Icn Canada Ltd. | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2004 | CLOBEX LOTION | Galderma Canada Inc. | New Drug Submission (NDS) · Other |
| July 29, 2004 | CLOBEX SHAMPOO | Galderma Canada Inc. | New Drug Submission (NDS) · Other |
| July 29, 2004 | CUTIVATE | Glaxosmithkline Consumer Healthcare Ulc | New Drug Submission (NDS) · Admin |
| July 29, 2004 | FOSAMAX | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| July 29, 2004 | FUROSEMIDE INJECTION USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| July 28, 2004 | PMS-GABAPENTIN | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| July 28, 2004 | TARO-GABAPENTIN | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| July 27, 2004 | REPRONEX | Ferring Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 27, 2004 | AVAPRO | Sanofi-Synthelabo Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 27, 2004 | TEQUIN | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 22, 2004 | LOPERACAP | Vita Health Products Inc. | New Drug Submission (NDS) · Admin |
| July 20, 2004 | ACTACEL | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 20, 2004 | ACTACEL | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 20, 2004 | ACT-HIB | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 20, 2004 | PENTACEL | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 20, 2004 | VIVAXIM | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| July 20, 2004 | DETROL LA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Admin |
| July 16, 2004 | RISPERDAL CONSTA; RISPERDAL CONSTA 3N | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 16, 2004 | PARIET | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 15, 2004 | PROSTEP | Aveva Drug Delivery Systems Inc. | New Drug Submission (NDS) · Admin |
| July 15, 2004 | DARVON-N | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| July 15, 2004 | DOM-FOSINOPRIL | Dominion Pharmacal | New Drug Submission (NDS) · Admin |
| July 15, 2004 | PHL-FOSINOPRIL | Pharmel Inc. | New Drug Submission (NDS) · Admin |
| July 15, 2004 | PLAN B | Duramed Pharmaceuticals, Inc., A Subsidiary Of Barr Pharmaceuticals, Inc. | New Drug Submission (NDS) · Admin |
| July 15, 2004 | PMS-FOSINOPRIL | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| July 15, 2004 | PROSCAR | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| July 8, 2004 | RIMADYL INJECTABLE | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| July 8, 2004 | CHOLETEC | Bracco Diagnostics Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| July 7, 2004 | REFACTO | Wyeth Canada | Supplement to a New Drug Submission (SNDS) · Other |
| July 5, 2004 | AGENERASE | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| July 5, 2004 | CO ATENOLOL | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| July 5, 2004 | CO FLUVOXAMINE | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| July 5, 2004 | NITRAZEPAM-10; NITRAZEPAM-5 | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| July 5, 2004 | RIVA-FLUCONAZOLE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 30, 2004 | APO-CLONIDINE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 30, 2004 | ARIMIDEX | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2004 | CONCERTA | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2004 | EXTRANEAL | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| June 30, 2004 | REMERON | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 25, 2004 | HERCEPTIN | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2004 | ALDARA 5% CREAM | 3M Pharmaceuticals, A Division Of 3M Canada Company | Supplement to a New Drug Submission (SNDS) · Other |
| June 24, 2004 | CENTRUM 8400; CENTRUM 8401; CENTRUM 8415 | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Other |
| June 22, 2004 | AVANDAMET | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 22, 2004 | AVANDIA | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| June 22, 2004 | OXYTROL | Watson Laboratories Inc | New Drug Submission (NDS) · Other |
| June 21, 2004 | MIDAMOR | Orbus Pharma Inc. | New Drug Submission (NDS) · Admin |
| June 21, 2004 | MODURET | Orbus Pharma Inc. | New Drug Submission (NDS) · Admin |
| June 21, 2004 | PHL-LOXAPINE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| June 21, 2004 | PHL-LOXAPINE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| June 21, 2004 | PREM-PAROXETINE | Prempharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| June 17, 2004 | CEREZYME | Genzyme Canada Inc | New Drug Submission (NDS) · Admin |
| June 17, 2004 | PHL-OXYBUTYNIN | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| June 14, 2004 | APO-AMILORIDE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| June 14, 2004 | CO-TERBINAFINE | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| June 14, 2004 | PHL-GEMFIBROZIL | Pharmel Inc. | New Drug Submission (NDS) · Admin |
| June 14, 2004 | PHL-LOXAPINE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| June 14, 2004 | TRINIPATCH | Triton Pharma Inc. | New Drug Submission (NDS) · Admin |
| June 11, 2004 | REVALOR-200 IMPLANTS | Intervet Canada Corp | New Drug Submission (NDS) · Other |
| June 11, 2004 | DIOVAN | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 11, 2004 | DIOVAN HCT | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2004 | AERODIOL | Servier Canada Inc. | New Drug Submission (NDS) · Other |
| June 10, 2004 | CYCLOMEN | Sanofi-Synthelabo Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 10, 2004 | PROVERA; PROVERA PAK | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| June 8, 2004 | AMINOSYN 5%; AMINOSYN 7%; AMINOSYN 8.5%; AMINOSYN 10% | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN II 7%; AMINOSYN II 8.5%; AMINOSYN II 10% | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN II 10%; AMINOSYN II 15% | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN-PF 7%; AMONISYN-PF 10% | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN II 10% WITH ELECTROLYTES | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN II WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN II WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | AMINOSYN II 7% M IN 10% DEXTROSE (DUAL CHAMBER); AMINOSYN II 8.5% M IN 20% DEXTROSE (DUAL CHAMBER) | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 8, 2004 | LESCOL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 8, 2004 | RHOXAL-GLICLAZIDE | Rhoxalpharma Inc. | New Drug Submission (NDS) · Admin |
| June 8, 2004 | TEVETEN PLUS | Solvay Pharma Inc. | New Drug Submission (NDS) · Other |
| June 4, 2004 | AMINOSYN II 4.25% WITH 10% DEXTROSE; AMINOSYN II 4.25% WITH 20% DEXTROSE | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 4, 2004 | AMINOSYN II 10% WITH 50% DEXTROSE | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 4, 2004 | AMINOSYN II 7% WITH 10% DEXTROSE; AMINOSYN II 7% WITH 50% DEXTROSE; AMINOSYN II 8.5% WITH 50% DEXTROSE | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 4, 2004 | PANCURONIUM BROMIDE | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| June 3, 2004 | FORTEO | Eli Lilly Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| June 3, 2004 | RATIO-ACLAVULANATE; RATIO-ACLAVULANATE 125 F; RATIO-ACLAVULANATE 250 F | Ratiopharm Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| June 2, 2004 | GLEEVEC | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 31, 2004 | ENHANCE (HYALURONIC ACID SODIUM SALT INJECTION) | Bioniche Animal Health Canada Inc | New Drug Submission (NDS) · Other |
| May 31, 2004 | OXYMYCINE LA (OXYTETRACYCLINE INJECTION) | Wyeth Animal Health, Division Of Wyeth Canada | New Drug Submission (NDS) · Other |
| May 31, 2004 | ALDURAZYME | Genzyme Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| May 28, 2004 | INFANRIX-HEXA | Glaxosmithkline Inc | New Drug Submission (NDS) · Other |
| May 28, 2004 | RAPAMUNE | Wyeth Canada | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2004 | NOVO-RANIDINE INJECTION | Novopharm Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 28, 2004 | NOVO-RANIDINE ORAL SOLUTION | Novopharm Limited | Supplement to a New Drug Submission (SNDS) · Other |
| May 27, 2004 | NOVO-SERTRALINE | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| May 25, 2004 | PREM-CITALOPRAM | Prempharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 21, 2004 | PLAVIX | Sanofi-Synthelabo Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 21, 2004 | LIDOCAINE HYDROCHLORIDE INJECTION 2%; LIDOCAINE HYDROCHLORIDE INJECTION 1% | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 21, 2004 | GEN-HYDROXYCHLOROQUINE | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 21, 2004 | ALIMTA | Eli Lilly Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| May 21, 2004 | 0.4% LIDOCAINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 20, 2004 | PMS-CIPROFLOXACIN 0.3% | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| May 20, 2004 | DOM-OXAZEPAM | Biomed 2002 Inc | New Drug Submission (NDS) · Admin |
| May 20, 2004 | CELEBREX | Pfizer Canada Ulc | New Drug Submission (NDS) · Other |
| May 19, 2004 | CONOFITE CREAM 2% | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| May 19, 2004 | SUROLAN DROPS | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| May 19, 2004 | VULKETAN (KETANSERIN (AS KETANSERIN TARTRATE) 0.25% W/W GEL) | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| May 19, 2004 | APAFER-200 | A.P.A., Division Of Vétoquinol N.-A. Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 19, 2004 | DEXAFER-200 | Vetoquinol N A Inc | Abbreviated New Drug Submission (ANDS) · Other |
| May 19, 2004 | IMAVEROL CONCENTRATED SOLUTION | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| May 19, 2004 | STRESNIL INJECTION (AZAPERONE) | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| May 19, 2004 | POLYFLEX (STERILE AMPICILLIN FOR INJECTABLE SUSPENSION, 10G/VIAL) | Wyeth Animal Health, Division Of Wyeth Canada | New Drug Submission (NDS) · Other |
| May 19, 2004 | POLYFLEX (STERILE AMPICILLIN TRIHYDRATE) | Wyeth Animal Health, Division Of Wyeth Canada | New Drug Submission (NDS) · Other |
| May 19, 2004 | APRALAN (APRAMYCIN SULFATE) SOLUBLE POWDER | Elanco, Division Of Eli Lilly Canada Inc. | New Drug Submission (NDS) · Other |
| May 18, 2004 | PHL-SIMVASTATIN | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 18, 2004 | FTP-DOMPERIDONE MALEATE | Gmd Distributing Inc. | New Drug Submission (NDS) · Admin |
| May 18, 2004 | DOM-SIMVASTATIN | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| May 18, 2004 | CORTROSYN | Amphastar Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| May 18, 2004 | ADVIL COLD AND SINUS PLUS | Wyeth Consumer Healthcare Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 17, 2004 | GENTAMICIN SULFATE IN 0.9% SODIUM CHLORIDE INJECTION | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 17, 2004 | DEFINITY | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2004 | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%; IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 5% | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2004 | GAMUNEX | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 14, 2004 | 4% CITANEST PLAIN DENTAL | Dentsply Canada Ltd. | Supplement to a New Drug Submission (SNDS) · Admin |
| May 14, 2004 | 4% CITANEST FORTE DENTAL WITH EPINEPHRINE 1:200,000 | Dentsply Canada Ltd. | Supplement to a New Drug Submission (SNDS) · Admin |
| May 13, 2004 | PROMETRIUM | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 13, 2004 | PMS-MEDROXYPROGESTERONE | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 13, 2004 | PHL-METOPROLOL-L | Pharmel Inc. | New Drug Submission (NDS) · Admin |
| May 13, 2004 | MEDROXYPROGESTERONE | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 13, 2004 | MEDROXY-2.5; MEDROXY-5 | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| May 13, 2004 | IMITREX DF | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Admin |
| May 13, 2004 | DOM-MEDROXYPROGESTERONE | Dominion Pharmacal | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| May 11, 2004 | VIGAMOX | Alcon Canada Inc. | New Drug Submission (NDS) · Other |
| May 11, 2004 | NUVARING | Organon Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| May 10, 2004 | PEGASYS RBV | Hoffmann-La Roche Limited | New Drug Submission (NDS) · Priority-NAS |
| May 10, 2004 | CIPRODEX | Alcon Canada Inc. | New Drug Submission (NDS) · Other |
| May 6, 2004 | GALLIUM (GA67) CITRATE INJECTION | Tyco Healthcare | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2004 | ORTHOCLONE OKT 3 | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2004 | RETAVASE | Centocor Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| May 6, 2004 | APO-MILRINONE INJECTABLE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 5, 2004 | ESTRING | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| May 5, 2004 | DOPAMINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 4, 2004 | MARCAINE | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 4, 2004 | MARCAINE E | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 4, 2004 | MARCAINE SPINAL | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| May 3, 2004 | DOM-PRAVASTATIN | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | GMD-BUSPIRONE | Gmd Distributing Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | GMD-CIPROFLOXACIN | Gmd Distributing Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | GMD-FAMOTIDINE | Gmd Distributing Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | GMD-METFORMIN | Gmd Distributing Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | PHL-PRAVASTATIN | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | RATIO-CARVEDILOL | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| May 3, 2004 | VECURONIUM BROMIDE FOR INJECTION | Hospira Healthcare Corporation | Abbreviated New Drug Submission (ANDS) · Admin |
| May 3, 2004 | CEFTIN | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 30, 2004 | MEGAMECTIN (IVERMECTIN) (INJECTION FOR CATTLE AND SWINE) | Novartis Animal Health Canada Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 30, 2004 | GMD-ATENOLOL | Gmd Distributing Inc. | New Drug Submission (NDS) · Admin |
| April 30, 2004 | GMD-DOMPERIDONE | Gmd Distributing Inc. | New Drug Submission (NDS) · Admin |
| April 30, 2004 | LIPOSYN II | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| April 30, 2004 | GMD-LOVASTATIN | Gmd Distributing Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 30, 2004 | GMD-TEMAZEPAM | Gmd Distributing Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 28, 2004 | AGRY-GEN | Shire Biochem Inc. | New Drug Submission (NDS) · Admin |
| April 26, 2004 | RATIO-CITALOPRAM | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| April 26, 2004 | PMS-OFLOXACIN | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 23, 2004 | GEN-MEDROXY | Genpharm Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 22, 2004 | CLOZARIL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 21, 2004 | NU-MEDROXY | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| April 21, 2004 | SAIZEN | Serono Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 21, 2004 | SEROSTIM | Serono Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 20, 2004 | VERAPAMIL HYDROCHLORIDE INJECTION USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| April 20, 2004 | PMS-SIMVASTATIN | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 20, 2004 | PHOSLO TABLETS | Nabi Biopharmaceuticals | New Drug Submission (NDS) · Admin |
| April 20, 2004 | NOVO-MEDRONE | Novopharm Limited | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 20, 2004 | TARO LORATADINE | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| April 19, 2004 | PENLAC | Dermik Laboratories Canada Inc. | New Drug Submission (NDS) · Other |
| April 16, 2004 | ESTROGEL | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 16, 2004 | NEISVAC-C | Shire Biologics, A Division Of Shire Biochem Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 16, 2004 | MYOBLOC | Elan Pharmaceuticals, Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| April 15, 2004 | FLOXIN | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 14, 2004 | DOM-MIRTAZAPINE | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| April 14, 2004 | PHL-TERAZOSIN | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 14, 2004 | PHL-SOTALOL | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 14, 2004 | PHL-MIRTAZAPINE | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| April 14, 2004 | PHL-INDAPAMIDE | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| April 14, 2004 | DOM-METOPROLOL-L | Dominion Pharmacal | New Drug Submission (NDS) · Admin |
| April 14, 2004 | LIBERATOR | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| April 13, 2004 | CASODEX | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| April 8, 2004 | CLIMARA PRO | Berlex Canada Inc. | New Drug Submission (NDS) · Other |
| April 8, 2004 | NU-CIPROFLOXACIN | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| April 7, 2004 | CIPRO XL | Bayer Inc. | New Drug Submission (NDS) · Other |
| April 5, 2004 | SOLOXINE (LEVOTHYROXINE SODIUM TABLETS 0.1MG) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| April 5, 2004 | SOLOXINE (LEVOTHYROXINE SODIUM TABLETS 0.2MG) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| April 5, 2004 | SOLOXINE (LEVOTHYROXINE SODIUM TABLETS 0.3MG) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| April 5, 2004 | SOLOXINE (LEVOTHYROXINE SODIUM TABLETS 0.5MG) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| April 5, 2004 | SOLOXINE (LEVOTHYROXINE SODIUM TABLETS 0.8MG) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| April 5, 2004 | AMIODARONE OMEGA | Omega Laboratories Limited | Abbreviated New Drug Submission (ANDS) · Other |
| April 5, 2004 | APO-MEDROXY | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| April 5, 2004 | LEVULAN KERASTICK | Dusa Pharmaceuticals Inc | New Drug Submission (NDS) · Admin |
| April 1, 2004 | ACT-HIB | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | INACTIVATED POLIOMYELITIS VACCINE (DCO) - IPV | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | IMMUCYST | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | DT POLIO ADSORBED | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | TD POLIO ADSORBED | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | QUADRACEL | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | PENTACEL | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | PEDIACEL | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | MEASLES VIRUS VACCINE, LIVE, ATTENUATED (DRIED) | Aventis Pasteur Limited | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | NOVO-CITALOPRAM | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| April 1, 2004 | PREVACID FASTAB | Tap Pharmaceuticals, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| April 1, 2004 | PHL-TRAZODONE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| March 31, 2004 | CIPROFLOXACIN | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| March 31, 2004 | MULTIHANCE | Bracco Diagnostics Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 31, 2004 | ZAVESCA | Actelion Pharmaceuticals Ltd | New Drug Submission (NDS) · Priority-NAS |
| March 30, 2004 | ACTIVELLE | Novo Nordisk Canada Inc | New Drug Submission (NDS) · Other |
| March 29, 2004 | ASPIRIN EXTRA STRENGTH | Bayer Inc., Consumer Care Division | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2004 | IMITREX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2004 | RATIO-FENOFIBRATE MC | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 29, 2004 | RHOXAL-MIRTAZAPINE | Rhoxalpharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 29, 2004 | RYTHMOL SR | Abbott Laboratories Co. | Supplement to a New Drug Submission (SNDS) · Other |
| March 29, 2004 | TARO-PHENYTOIN | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| March 26, 2004 | HELIXATE FS | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 26, 2004 | PRAVACHOL | Bristol-Myers Squibb Canada | Supplement to a New Drug Submission (SNDS) · Other |
| March 26, 2004 | KALETRA | Abbott Laboratories Co. | Supplement to a New Drug Submission (SNDS) · Other |
| March 25, 2004 | ADVIL COLD AND SINUS LIQUI-GELS | Wyeth Consumer Healthcare Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 25, 2004 | NOVO-ZOPICLONE | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Admin |
| March 25, 2004 | VISUDYNE | Qlt Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 24, 2004 | DIAZEMULS | Alpharma Inc. | New Drug Submission (NDS) · Admin |
| March 24, 2004 | DOM-CIPROFLOXACIN | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| March 24, 2004 | PHL-CIPROFLOXACIN | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 24, 2004 | RIVA-CIPROFLOXACIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 24, 2004 | RIVA-GABAPENTIN | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 23, 2004 | BONVIVA | Hoffmann-La Roche Limited | New Drug Submission (NDS) · Other |
| March 23, 2004 | CYTOSAR | Pfizer Canada Ulc | New Drug Submission (NDS) · Admin |
| March 23, 2004 | ZOCOR | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| March 23, 2004 | NU-VERAP SR | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 23, 2004 | RIVA-CITALOPRAM | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 22, 2004 | FLUMAZENIL INJECTION | Sabex 2002 Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 22, 2004 | LESCOL XL | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 22, 2004 | CO MELOXICAM | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| March 19, 2004 | NOVO-SIMVASTATIN | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| March 19, 2004 | PMS-METOPROLOL-L | Pharmascience Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 18, 2004 | ANDRIOL | Organon Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 17, 2004 | LEVITRA | Bayer Inc., Healthcare Division | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 15, 2004 | GASTROGARD | Merial Canada Inc. | New Drug Submission (NDS) · Other |
| March 15, 2004 | STERILE VANCOMYCIN HYDROCHLORIDE USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| March 15, 2004 | NORPROLAC | Ferring Inc. | New Drug Submission (NDS) · Admin |
| March 15, 2004 | ARIXTRA | Organon Sanofi-Synthelabo Canada | Supplement to a New Drug Submission (SNDS) · Other |
| March 15, 2004 | FENTANYL CITRATE INJECTION | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| March 15, 2004 | PREFESTA | Janssen-Ortho Inc. | New Drug Submission (NDS) · Other |
| March 15, 2004 | DOBUTAMINE HYDROCHLORIDE INJECTION USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| March 15, 2004 | BUPIVACAINE HYDROCHLORIDE INJECTION USP | Hospira Healthcare Corporation | New Drug Submission (NDS) · Admin |
| March 15, 2004 | ENDANTADINE | Bristol-Myers Squibb Canada | New Drug Submission (NDS) · Admin |
| March 12, 2004 | NEULASTA | Amgen Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 10, 2004 | TUMIL-K TABLETS (POTASSIUM GLUCONATE USP) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| March 10, 2004 | TUMIL-K POWDER (POTASSIUM GLUCONATE USP) | Virbac Ah, Inc. | New Drug Submission (NDS) · Other |
| March 10, 2004 | ANTIZOL-VET (FOMEPIZOLE) FOR INJECTION | Orphan Medical Inc. | New Drug Submission (NDS) · Other |
| March 10, 2004 | APO-CYPROTERONE | Apotex Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| March 9, 2004 | MARQUIS (ANTIPROTOZOAL ORAL PASTE FOR HORSES) | Bayer Inc., Agriculture Division, Animal Health | New Drug Submission (NDS) · Other |
| March 9, 2004 | PHL-PAROXETINE | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 9, 2004 | PAMIDRONATE DISODIUM OMEGA | Omega Laboratories Limited | Abbreviated New Drug Submission (ANDS) · Other |
| March 9, 2004 | FACTIVE | Lg Life Sciences Ltd. | New Drug Submission (NDS) · New Active Substance (NAS) |
| March 9, 2004 | CLIMARA | Berlex Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 9, 2004 | BRIMONIDINE | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| March 8, 2004 | VIAGRA | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| March 5, 2004 | APRESOLINE | Sterimax Inc. | New Drug Submission (NDS) · Admin |
| March 4, 2004 | IVEEGAM IMMUNO | Baxter Corporation | Supplement to a New Drug Submission (SNDS) · Admin |
| March 3, 2004 | SANOREX | Sterimax Inc. | New Drug Submission (NDS) · Admin |
| March 3, 2004 | MIGRANAL | Sterimax Inc. | New Drug Submission (NDS) · Admin |
| March 3, 2004 | NU-CITALOPRAM | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| March 3, 2004 | GEN-CLARITHROMYCIN (FILM-COATED TABLETS) | Genpharm Inc. | New Drug Submission (NDS) · Admin |
| March 3, 2004 | PHL-CARVEDILOL | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 2, 2004 | LINCOMIX SOLUBLE POWDER | Pfizer Canada Inc., Animal Health Group | Supplement to a New Drug Submission (SNDS) · Other |
| March 2, 2004 | LINCOMIX SOLUBLE POWDER | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| March 2, 2004 | ZOMIG NASAL SPRAY | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 2, 2004 | IMITREX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| March 2, 2004 | SALBUTAMOL INHALATION SOLUTION | Ivax Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Admin |
| March 2, 2004 | LEVAQUIN | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 2, 2004 | LEVAQUIN | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| March 2, 2004 | RIVA-BUSPIRONE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| March 1, 2004 | ADVIL JUNIOR STRENGTH CHEWABLE TABLETS; CHILDREN'S ADVIL CHEWABLE TABLETS | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| March 1, 2004 | ADVIL LIQUI-GELS; ADVIL EXTRA STRENGTH LIQUI-GELS | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| March 1, 2004 | ADVIL EXTRA STRENGTH CAPLETS; ADVIL GEL CAPLETS; ADVIL IBUPROFEN TABLETS; ADVIL IBUPROFEN CAPLETS | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| March 1, 2004 | ESTRACE | Shire Biochem Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 27, 2004 | TARO-FLUCONAZOLE | Taro Pharmaceuticals Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 26, 2004 | LINCOMIX 44 PREMIX | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| February 26, 2004 | LINCOMIX 44 PREMIX | Pfizer Canada Inc., Animal Health Group | Supplement to a New Drug Submission (SNDS) · Other |
| February 26, 2004 | LINCOMIX 110 PREMIX | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| February 26, 2004 | LINCOMIX 110 PREMIX | Pfizer Canada Inc., Animal Health Group | Supplement to a New Drug Submission (SNDS) · Other |
| February 26, 2004 | VALCYTE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 26, 2004 | PHL-TRAZODONE | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| February 26, 2004 | RIVA-RANITIDINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 26, 2004 | CENTRUM 8285 | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| February 26, 2004 | CENTRUM 8390 | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| February 26, 2004 | NU-FENO-MICRO | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| February 26, 2004 | PREM-CIPROFLOXACIN | Prempharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 25, 2004 | TRIMIDOX (STERILE INJECTABLE SOLUTION) | Vetoquinol N A Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 23, 2004 | PROGRAF | Fujisawa Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 23, 2004 | FEMHRT | Galen (Chemicals) Ltd | Supplement to a New Drug Submission (SNDS) · Other |
| February 23, 2004 | ELIGARD | Sanofi-Synthelabo Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 20, 2004 | RUMENSIN CRC (CONTROLLED RELEASE CAPSULE) | Elanco, Division Of Eli Lilly Canada Inc. | New Drug Submission (NDS) · Other |
| February 18, 2004 | SPECTAM WATER SOLUBLE CONCENTRATE | Vetoquinol N A Inc | New Drug Submission (NDS) · Other |
| February 18, 2004 | CIPROFLOXACIN TABLETS USP | Dr Reddys Laboratories Ltd | Abbreviated New Drug Submission (ANDS) · Other |
| February 18, 2004 | CO CIPROFLOXACIN TABLET | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| February 18, 2004 | DOM-CARVEDILOL | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| February 18, 2004 | GEN-CIPROFLOXACIN | Genpharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 18, 2004 | NOVO-CIPROFLOXACIN | Novopharm Limited | Abbreviated New Drug Submission (ANDS) · Other |
| February 18, 2004 | PMS-CIPROFLOXACIN | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 18, 2004 | PMS-CIPROFLOXACIN | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 18, 2004 | RATIO-CIPROFLOXACIN | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 18, 2004 | RATIO-CIPROFLOXACIN | Ratiopharm Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 18, 2004 | RHOXAL-CIPROFLOXACIN | Rhoxalpharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 17, 2004 | NUTROPIN AQ PEN CARTRIDGE | Hoffmann-La Roche Limited | Supplement to a New Drug Submission (SNDS) · Other |
| February 17, 2004 | PIPERACILLIN FOR INJECTION USP | Pharmaceutical Partners Of Canada Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 17, 2004 | GABAPENTIN | Prempharm Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 17, 2004 | FASLODEX | Astrazeneca Canada Inc | New Drug Submission (NDS) · New Active Substance (NAS) |
| February 17, 2004 | APO-ALENDRONATE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 16, 2004 | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 5%; IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10% | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 16, 2004 | GAMUNEX | Bayer Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2004 | BAYTRIL 100 | Bayer Inc., Agriculture Division, Animal Health | New Drug Submission (NDS) · Other |
| February 12, 2004 | VALTREX | Glaxosmithkline Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2004 | SONOVUE | Bracco Diagnostics Canada Inc. | New Drug Submission (NDS) · New Active Substance (NAS) |
| February 12, 2004 | CRESTOR | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| February 12, 2004 | NU-PROPAFENONE | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| February 12, 2004 | NU-PAROXETINE | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| February 12, 2004 | FENTANYL TRANSDERMAL SYSTEM | Janssen-Ortho Inc. | New Drug Submission (NDS) · Admin |
| February 12, 2004 | PHL-CYCLOBENZAPRINE | Pharmel Inc. | New Drug Submission (NDS) · Admin |
| February 12, 2004 | PHL-BACLOFEN | Pharmel Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| February 12, 2004 | PHL-AMIODARONE | Pharmel Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Admin |
| February 11, 2004 | CO-LOVASTATIN | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| February 10, 2004 | METASTRON | Amersham Health Inc. | New Drug Submission (NDS) · Admin |
| February 10, 2004 | REMICADE | Centocor Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 9, 2004 | ACID REDUCER | Pharmascience Inc. | Supplement to an Abbreviated New Drug Submission (SANDS) · Other |
| February 9, 2004 | APO-PACLITAXEL INJECTABLE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 9, 2004 | APO-CIPROFLOX | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| February 9, 2004 | APO-CIPROFLOX | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 9, 2004 | APO-CIPROFLOX | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 6, 2004 | LEVAQUIN | Janssen-Ortho Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| February 6, 2004 | REPLAGAL | Transkaryotic Therapies Inc. | New Drug Submission (NDS) · Priority-NAS |
| February 5, 2004 | PAROXETINE | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| February 3, 2004 | APO-MELOXICAM | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| February 3, 2004 | FLUCONAZOLE INJECTION | Pharmaceutical Partners Of Canada Inc | Abbreviated New Drug Submission (ANDS) · Other |
| February 3, 2004 | VANIQA | Shire Biochem Inc. | New Drug Submission (NDS) · Admin |
| February 2, 2004 | SULCRATE; SULCRATE SUSPENSION PLUS | Axcan Pharma Inc. | New Drug Submission (NDS) · Admin |
| January 29, 2004 | UNITRON PEG | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2004 | PREVACID | Tap Pharmaceuticals, Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 29, 2004 | DIARRHEA RELIEF | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| January 29, 2004 | PMS-IPRATROPIUM | Pharmascience Inc. | New Drug Submission (NDS) · Admin |
| January 29, 2004 | NU-CARVEDILOL | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 29, 2004 | SIMULECT | Novartis Pharmaceuticals Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 28, 2004 | NOROMYCIN LP (STERILE INJECTABLE SOLUTION) | Norbrook Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| January 28, 2004 | GALLIMYCIN-36 (ERYTHROMYCIN INTRAMAMMARY INFUSION) | Vetoquinol N A Inc | New Drug Submission (NDS) · Other |
| January 28, 2004 | ATACAND; ATACAND PLUS | Astrazeneca Canada Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 27, 2004 | PMS-PAMIDRONATE | Pharmascience Inc. | New Drug Submission (NDS) · Other |
| January 27, 2004 | CORTIFOAM | Paladin Labs Inc | New Drug Submission (NDS) · Admin |
| January 27, 2004 | GADOVIST 1.0 | Berlex Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 26, 2004 | RHOXAL-CITALOPRAM | Rhoxalpharma Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 23, 2004 | TOBRAMYCIN FOR INJECTION USP | Pharmaceutical Partners Of Canada Inc | New Drug Submission (NDS) · Admin |
| January 23, 2004 | RETIN-A MICRO GEL | Johnson & Johnson Inc | New Drug Submission (NDS) · Admin |
| January 23, 2004 | RAMACE | Aventis Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 23, 2004 | NARDIL | Pfizer Canada Ulc | Supplement to a New Drug Submission (SNDS) · Other |
| January 23, 2004 | OXIZOLE CREAM 1% | Valeo Pharma Inc. | New Drug Submission (NDS) · Admin |
| January 23, 2004 | PHL-CITALOPRAM | Pharmel Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 23, 2004 | DOM-CITALOPRAM | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| January 23, 2004 | ADDERALL XR | Shire Biochem Inc. | New Drug Submission (NDS) · Other |
| January 23, 2004 | FABRAZYME | Genzyme Canada Inc | New Drug Submission (NDS) · Priority-NAS |
| January 20, 2004 | MYOVIEW | Amersham Health Inc. | New Drug Submission (NDS) · Admin |
| January 20, 2004 | CERETEC | Amersham Health Inc. | New Drug Submission (NDS) · Admin |
| January 20, 2004 | CO-ETIDRONATE | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| January 19, 2004 | APO-TAMOX | Apotex Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 19, 2004 | CO CITALOPRAM | Cobalt Pharmaceuticals Incorporated | Abbreviated New Drug Submission (ANDS) · Other |
| January 19, 2004 | FOSAMAX | Merck Frosst Canada & Cie, Merck Frosst Canada & Co. | Supplement to a New Drug Submission (SNDS) · Other |
| January 15, 2004 | RAMACE | Aventis Pharma Inc. | Supplement to a New Drug Submission (SNDS) · Admin |
| January 15, 2004 | SAB-OPTICORT | Sabex 2002 Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 15, 2004 | APO-ATENIDONE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 15, 2004 | APO-ATENIDONE | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2004 | CYCLOSOL 200 LA INJECTABLE SOLUTION | Eurovet Animal Health B.V. | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2004 | NU-TERBINAFINE | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 14, 2004 | CIDR CATTLE DEVICE (INTRAVAGINAL PROGESTERONE RELEASE DEVICE) | Pfizer Canada Inc., Animal Health Group | New Drug Submission (NDS) · Other |
| January 14, 2004 | PMS-MIRTAZAPINE | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2004 | MISOPROSTOL-200 | Pro Doc Limitee | Abbreviated New Drug Submission (ANDS) · Admin |
| January 14, 2004 | NU-AZATHIOPRINE | Nu-Pharm Inc | Abbreviated New Drug Submission (ANDS) · Admin |
| January 14, 2004 | SUPPRESSOR (STERILE INJECTABLE SOLUTION) | Norbrook Laboratories Ltd. | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2004 | PMS-CITALOPRAM | Pharmascience Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 14, 2004 | RATIO-AMCINONIDE | Ratiopharm Inc. | New Drug Submission (NDS) · Admin |
| January 12, 2004 | NOROMYCIN LA (STERILE INJECTABLE SOLUTION) | Norbrook Laboratories Ltd. | New Drug Submission (NDS) · Other |
| January 12, 2004 | ACULAR LS | Allergan Inc | Supplement to a New Drug Submission (SNDS) · Other |
| January 12, 2004 | APO-CITALOPRAM | Apotex Inc. | Abbreviated New Drug Submission (ANDS) · Other |
| January 9, 2004 | DOM-PAROXETINE | Dominion Pharmacal | Abbreviated New Drug Submission (ANDS) · Admin |
| January 9, 2004 | RIVA-PAROXETINE | Laboratoire Riva Inc. | Abbreviated New Drug Submission (ANDS) · Admin |
| January 9, 2004 | ADVIL COLD AND SINUS CAPLETS | Wyeth Consumer Healthcare Inc. | New Drug Submission (NDS) · Admin |
| January 8, 2004 | INTRON A | Schering Canada Inc. | Supplement to a New Drug Submission (SNDS) · Other |
| January 8, 2004 | ENBREL | Immunex Corporation | Supplement to a New Drug Submission (SNDS) · Other |
| January 5, 2004 | OCTREOTIDE ACETATE OMEGA | Omega Laboratories Limited | Abbreviated New Drug Submission (ANDS) · Other |
| January 2, 2004 | CHIROCAINE | Abbott Laboratories Co. | Supplement to a New Drug Submission (SNDS) · Other |