# AVGEMSI
> **NDA219920** · New Drug Application · Sponsor: AVYXA HOLDINGS · Approved 2025-06-27
## Drug
- **FDA Application Number:** NDA219920
- **Application type:** New Drug Application
- **Brand name:** AVGEMSI
- **Generic name:** GEMCITABINE
- **Active ingredients:** GEMCITABINE HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** AVYXA HOLDINGS
- **Manufacturer:** Avyxa Pharma, LLC
- **First approval:** 2025-06-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219920)
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