FdaApplication
ANDA 075945
Identifiers
- fda_app_no: ANDA075945
Properties
| Property | Value |
|---|---|
| applicant_name | MYLAN PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2002-11-08 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AMNESTEEM | ISOTRETINOIN | 10MG | CAPSULE;ORAL |
| AMNESTEEM | ISOTRETINOIN | 40MG | CAPSULE;ORAL |
| AMNESTEEM | ISOTRETINOIN | 20MG | CAPSULE;ORAL |
| AMNESTEEM | ISOTRETINOIN | 30MG | CAPSULE;ORAL |
4 products