FdaApplication
ANDA 208443
Identifiers
- fda_app_no: ANDA208443
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2024-01-16 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FIDAXOMICIN | FIDAXOMICIN | 200MG | TABLET;ORAL |
1 product