# GEMCITABINE
> **ANDA078460** · Abbreviated New Drug Application (Generic) · Sponsor: EUROHLTH INTL · Approved 2010-01-19
## Drug
- **FDA Application Number:** ANDA078460
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GEMCITABINE
- **Generic name:** Gemcitabine
- **Active ingredients:** GEMCITABINE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** EUROHLTH INTL
- **First approval:** 2010-01-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078460)
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