Application 078986
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6885 | Carbamazepine | Carbamazepine | Major Pharmaceuticals | ANDA | Current |
| 0904-6885 | Carbamazepine | Carbamazepine | Major Pharmaceuticals | ANDA | Current |
| 50268-170 | Carbamazepine | Carbamazepine | AvPAK | ANDA | Current |
| 50268-170 | Carbamazepine | Carbamazepine | AvPAK | ANDA | Current |
| 50268-171 | Carbamazepine | Carbamazepine | AvPAK | ANDA | Current |
| 50268-171 | Carbamazepine | Carbamazepine | AvPAK | ANDA | Current |
| 50268-172 | Carbamazepine | Carbamazepine | AvPAK | ANDA | Current |
| 50268-172 | Carbamazepine | Carbamazepine | AvPAK | ANDA | Current |
| 60505-2805 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2805 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2805 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2805 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2806 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2806 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2806 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2806 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2807 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2807 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2807 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 60505-2807 | Carbamazepine | Carbamazepine | Apotex Corp. | ANDA | Current |
| 63629-8720 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8720 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8720 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8721 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8721 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8721 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 70518-3176 | Carbamazepine | Carbamazepine | REMEDYREPACK INC. | ANDA | Current |