Application 219323
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Related Records
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 | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 84989 | 0 | ORIG | 1 | 2026-02-11 | Cached in FDA.report object storage |