Application 200891
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43353-165 | Memantine Hydrochloride | memantine hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 46708-451 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-451 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-452 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-452 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-075 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-075 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-075 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-076 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-076 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-076 | Memantine Hydrochloride | memantine hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |