Application 215570
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALBOCICLIB | PALBOCICLIB | TABLET;ORAL | 75MG | No | No |
| 002 | PALBOCICLIB | PALBOCICLIB | TABLET;ORAL | 100MG | No | No |
| 003 | PALBOCICLIB | PALBOCICLIB | TABLET;ORAL | 125MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75397 | ORIG | 2023-09-12 |