Application 208324
- 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, ORALLY DISINTEGRATING;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-235 | Vardenafil | Vardenafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-235 | Vardenafil | Vardenafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-235 | Vardenafil | Vardenafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-235 | Vardenafil | Vardenafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-235 | Vardenafil | Vardenafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56851 | ORIG | 2018-12-20 |