# GEMCITABINE HYDROCHLORIDE
> **ANDA078433** · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2011-07-25
## Drug
- **FDA Application Number:** ANDA078433
- **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:** Prescription
- **Sponsor:** SUN PHARM
- **First approval:** 2011-07-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078433)
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