Drug application
DAUNORUBICIN HYDROCHLORIDE (DAUNORUBICIN HYDROCHLORIDE)
Drugs@FDA ANDA 065034 · FRESENIUS KABI USA
Key facts
| Drug name | DAUNORUBICIN HYDROCHLORIDE |
|---|---|
| Active ingredients | DAUNORUBICIN HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 065034 |
| Company | FRESENIUS KABI USA |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | EQ 5MG BASE/VIAL |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Nov 20, 2001 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: