# GEMCITABINE HYDROCHLORIDE
> **ANDA090242** · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2011-05-17
## Drug
- **FDA Application Number:** ANDA090242
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GEMCITABINE HYDROCHLORIDE
- **Generic name:** Gemcitabine Hydrochloride
- **Active ingredients:** GEMCITABINE HYDROCHLORIDE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** FRESENIUS KABI USA
- **First approval:** 2011-05-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090242)
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