FdaApplication
ANDA 215948
Identifiers
- fda_app_no: ANDA215948
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2024-02-12 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MIRABEGRON | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE;ORAL |
| MIRABEGRON | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE;ORAL |
2 products