# GEMCITABINE HYDROCHLORIDE
> **ANDA205242** · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN LABS LTD · Approved 2017-12-06
## Drug
- **FDA Application Number:** ANDA205242
- **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:** MYLAN LABS LTD
- **Manufacturer:** Mylan Institutional LLC
- **First approval:** 2017-12-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205242)
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