Application 209488
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRABEGRON | MIRABEGRON | TABLET, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 002 | MIRABEGRON | MIRABEGRON | TABLET, EXTENDED RELEASE;ORAL | 50MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58807 | ORIG | 2019-05-21 |