FdaApplication
ANDA 065331
Identifiers
- fda_app_no: ANDA065331
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2007-08-09 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION |
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION |
2 products