Application 216594
- 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, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59746-789 | Carbamazepine | Carbamazepine | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-789 | Carbamazepine | Carbamazepine | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-790 | Carbamazepine | Carbamazepine | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-790 | Carbamazepine | Carbamazepine | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-791 | Carbamazepine | Carbamazepine | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-791 | Carbamazepine | Carbamazepine | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |