Application 204973
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 4MG | No | No |
| 002 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 8MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62332-175 | Fesoterodine Fumarate | Fesoterodine Fumarate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-176 | Fesoterodine Fumarate | Fesoterodine Fumarate | Alembic Pharmaceuticals Inc. | ANDA | Current |