Application 214031
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-236 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-237 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-238 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-239 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-236 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-236 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-236 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-237 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-237 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-237 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-238 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-238 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-238 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-239 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-239 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-239 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ANDA | Current |