Application 219323
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRABEGRON | MIRABEGRON | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 8MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84989 | ORIG | 2026-02-11 |