Application 211823
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | CAPSULE;ORAL | EQ 30MG BASE | No | No |
| 002 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | CAPSULE;ORAL | EQ 45MG BASE | No | No |
| 003 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-413 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-414 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-415 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-413 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-413 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-413 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-413 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-413 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-414 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-414 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-414 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-414 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-414 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-415 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-415 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-415 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-415 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-415 | OSELTAMIVIR | OSELTAMIVIR | Alembic Pharmaceuticals Inc. | ANDA | Current |