FdaApplication
ANDA 212490
Identifiers
- fda_app_no: ANDA212490
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2023-04-18 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROFLUMILAST | ROFLUMILAST | 500MCG | TABLET;ORAL |
| ROFLUMILAST | ROFLUMILAST | 250MCG | TABLET;ORAL |
2 products