APO-OXCARBAZEPINE DIN 02284316
Health Canada record
| Active ingredient(s) | OXCARBAZEPINE 600 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AF02 OXCARBAZEPINE |
| Original market date | 01-Aug-2006 |
| Current status date | 08-Jun-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing OXCARBAZEPINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02284308 | APO-OXCARBAZEPINE | APOTEX INC | Tablet | OXCARBAZEPINE 300 MG | Marketed |
| 02284294 | APO-OXCARBAZEPINE | APOTEX INC | Tablet | OXCARBAZEPINE 150 MG | Marketed |
| 02560615 | JAMP OXCARBAZEPINE | JAMP PHARMA CORPORATION | Tablet | OXCARBAZEPINE 600 MG | Marketed |
| 02560607 | JAMP OXCARBAZEPINE | JAMP PHARMA CORPORATION | Tablet | OXCARBAZEPINE 300 MG | Marketed |
| 02560593 | JAMP OXCARBAZEPINE | JAMP PHARMA CORPORATION | Tablet | OXCARBAZEPINE 150 MG | Marketed |
| 02439751 | OXCARBAZEPINE | JUBILANT GENERICS LIMITED | Tablet | OXCARBAZEPINE 300 MG | Approved |
| 02439743 | OXCARBAZEPINE | JUBILANT GENERICS LIMITED | Tablet | OXCARBAZEPINE 150 MG | Approved |
| 02439778 | OXCARBAZEPINE | JUBILANT GENERICS LIMITED | Tablet | OXCARBAZEPINE 600 MG | Approved |
| 02242068 | TRILEPTAL 300 MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | OXCARBAZEPINE 300 MG | Marketed |
| 02242069 | TRILEPTAL 600 MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | OXCARBAZEPINE 600 MG | Marketed |
| 02244673 | TRILEPTAL ORAL SUSPENSION | NOVARTIS PHARMACEUTICALS CANADA INC | Suspension | OXCARBAZEPINE 60 MG | Marketed |
| 02440733 | JAMP-OXCARBAZEPINE | JAMP PHARMA CORPORATION | Tablet | OXCARBAZEPINE 600 MG | Cancelled Post Market |
| 02440717 | JAMP-OXCARBAZEPINE | JAMP PHARMA CORPORATION | Tablet | OXCARBAZEPINE 150 MG | Cancelled Post Market |
| 02440725 | JAMP-OXCARBAZEPINE | JAMP PHARMA CORPORATION | Tablet | OXCARBAZEPINE 300 MG | Cancelled Post Market |
| 02312034 | NOVO-OXCARBAZEPINE | NOVOPHARM LIMITED | Tablet | OXCARBAZEPINE 300 MG | Cancelled Pre Market |
| 02312026 | NOVO-OXCARBAZEPINE | NOVOPHARM LIMITED | Tablet | OXCARBAZEPINE 150 MG | Cancelled Pre Market |
| 02312042 | NOVO-OXCARBAZEPINE | NOVOPHARM LIMITED | Tablet | OXCARBAZEPINE 600 MG | Cancelled Pre Market |
| 02466317 | SANDOZ OXCARBAZEPINE | SANDOZ CANADA INCORPORATED | Tablet | OXCARBAZEPINE 600 MG | Cancelled Pre Market |
| 02466295 | SANDOZ OXCARBAZEPINE | SANDOZ CANADA INCORPORATED | Tablet | OXCARBAZEPINE 150 MG | Cancelled Pre Market |
| 02466309 | SANDOZ OXCARBAZEPINE | SANDOZ CANADA INCORPORATED | Tablet | OXCARBAZEPINE 300 MG | Cancelled Pre Market |
| 02242067 | TRILEPTAL 150 MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | OXCARBAZEPINE 150 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18164 | 2016-06-08 | Abbreviated New Drug Submission (ANDS) | TRANSFER OF DRUG IDENTIFICATION NUMBERS |
| 16961 | 2015-06-03 | Abbreviated New Drug Submission (ANDS) | TRANSFER OF DRUG IDENTIFICATION NUMBERS |
| 8185 | 2006-07-31 | Abbreviated New Drug Submission (ANDS) |
International API supply for OXCARBAZEPINE
11 valid EDQM Certificates of Suitability from 11 holders. 20 active FDA Drug Master Files.
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