Application 211542
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 7.5MG | No | No |
| 002 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 15MG | No | No |
| 003 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 22.5MG | No | No |
| 004 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-379 | Temazepam | Temazepam | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-380 | Temazepam | Temazepam | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-381 | Temazepam | Temazepam | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-382 | Temazepam | Temazepam | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-379 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-379 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-379 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-379 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-380 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-380 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-380 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-380 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-381 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-381 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-381 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-381 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-382 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-382 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-382 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-382 | Temazepam | Temazepam | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 70518-3093 | Temazepam | Temazepam | REMEDYREPACK INC. | ANDA | Current |
| 70518-3605 | Temazepam | Temazepam | REMEDYREPACK INC. | ANDA | Current |
| 71335-2043 | Temazepam | Temazepam | Bryant Ranch Prepack | ANDA | Current |