Application 211568
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No |
| 002 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No |
| 003 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No |
| 004 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76357 | ORIG | 2023-11-06 |