Application 201724
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6408 | Donepezil Hydrochloride | Donepezil Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6409 | Donepezil Hydrochloride | Donepezil Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 46708-092 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-093 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-295 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-295 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-296 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-296 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 55154-6891 | Donepezil Hydrochloride | Donepezil Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6891 | Donepezil Hydrochloride | Donepezil Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7632 | Donepezil Hydrochloride | Donepezil Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7632 | Donepezil Hydrochloride | Donepezil Hydrochloride | Cardinal Health | ANDA | Current |
| 62332-092 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-092 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-092 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-093 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-093 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-093 | Donepezil Hydrochloride | Donepezil Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 70518-1445 | Donepezil Hydrochloride | Donepezil Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1445 | Donepezil Hydrochloride | Donepezil Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0876 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0876 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0876 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |