Application 211774
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | APREMILAST | APREMILAST | UNKNOWN | UNKNOWN | No | No |
| 002 | APREMILAST | APREMILAST | TABLET;ORAL | 20MG | No | No |
| 003 | APREMILAST | APREMILAST | TABLET;ORAL | 30MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67038 | ORIG | 2021-04-13 |