Application 207681
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 7.5MG BASE | No | No |
| 002 | DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 15MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-223 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-223 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-224 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-224 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-223 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-223 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-223 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-223 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-224 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-224 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-224 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-224 | DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | ANDA | Current |