Application 213091
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALBOCICLIB | PALBOCICLIB | CAPSULE;ORAL | 75MG | No | No |
| 002 | PALBOCICLIB | PALBOCICLIB | CAPSULE;ORAL | 100MG | No | No |
| 003 | PALBOCICLIB | PALBOCICLIB | CAPSULE;ORAL | 125MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68524 | ORIG | 2021-09-02 |