FdaApplication
ANDA 216097
Identifiers
- fda_app_no: ANDA216097
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS OF NY LLC |
| application_type | ANDA |
| approval_date | 2025-10-07 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL |
6 products