FdaApplication
ANDA 219323
Identifiers
- fda_app_no: ANDA219323
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2026-01-20 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MIRABEGRON | MIRABEGRON | 8MG/ML | FOR SUSPENSION, EXTENDED RELEASE;ORAL |
1 product