Drug application
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)
Drugs@FDA ANDA 090242 · FRESENIUS KABI USA
Key facts
| Drug name | GEMCITABINE HYDROCHLORIDE |
|---|---|
| Active ingredients | GEMCITABINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 090242 |
| Company | FRESENIUS KABI USA |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | EQ 200MG BASE/VIAL |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | May 17, 2011 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
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.