FdaApplication
ANDA 205063
Identifiers
- fda_app_no: ANDA205063
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2021-03-31 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL |
6 products