FdaApplication
ANDA 065440
Identifiers
- fda_app_no: ANDA065440
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS KABI USA LLC |
| application_type | ANDA |
| approval_date | 2009-08-04 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML) | SOLUTION;INTRAVENOUS |
3 products