Application 207798
- Type
- ANDA
- Sponsor
- UMEDICA LABS PVT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-5740 | Carbamazepine | Carbamazepine | A-S Medication Solutions | ANDA | Current |
| 50090-5740 | Carbamazepine | Carbamazepine | A-S Medication Solutions | ANDA | Current |
| 68788-7825 | Carbamazepine | Carbamazepine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7825 | Carbamazepine | Carbamazepine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2841 | Carbamazepine | Carbamazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2841 | Carbamazepine | Carbamazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2841 | Carbamazepine | Carbamazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2841 | Carbamazepine | Carbamazepine | REMEDYREPACK INC. | ANDA | Current |
| 71335-1730 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1730 | Carbamazepine | Carbamazepine | Bryant Ranch Prepack | ANDA | Current |
| 72189-157 | CARBAMAZEPINE | CARBAMAZEPINE | direct rx | ANDA | Current |
| 75834-220 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-220 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-220 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-220 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-220 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-221 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-221 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-221 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-221 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-221 | Carbamazepine | Carbamazepine | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |