Application 090430
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 002 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 450MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-025 | Theophylline | Theophylline | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-025 | Theophylline | Theophylline | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-025 | Theophylline | Theophylline | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-026 | Theophylline | Theophylline | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-026 | Theophylline | Theophylline | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-026 | Theophylline | Theophylline | Alembic Pharmaceuticals Limited | ANDA | Current |
| 53808-0982 | Theophylline | Theophylline | State of Florida DOH Central Pharmacy | ANDA | Current |
| 62332-025 | Theophylline | Theophylline | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-025 | Theophylline | Theophylline | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-025 | Theophylline | Theophylline | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-026 | Theophylline | Theophylline | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-026 | Theophylline | Theophylline | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-026 | Theophylline | Theophylline | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 68151-1393 | Theophylline | Theophylline | Carilion Materials Management | ANDA | Current |