FdaApplication
ANDA 211000
Identifiers
- fda_app_no: ANDA211000
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2026-06-08 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MACITENTAN | MACITENTAN | 10MG | TABLET;ORAL |
1 product