FdaApplication
ANDA 211128
Identifiers
- fda_app_no: ANDA211128
Properties
| Property | Value |
|---|---|
| applicant_name | ALEMBIC PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2025-08-18 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MACITENTAN | MACITENTAN | 10MG | TABLET;ORAL |
1 product