Application 215238
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IVABRADINE HYDROCHLORIDE | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | IVABRADINE HYDROCHLORIDE | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71924 | ORIG | 2022-08-26 |