# INLEXZO
> **NDA219683** · New Drug Application · Sponsor: JANSSEN BIOTECH · Approved 2025-09-09
## Drug
- **FDA Application Number:** NDA219683
- **Application type:** New Drug Application
- **Brand name:** INLEXZO
- **Generic name:** GEMCITABINE INTRAVESICAL
- **Active ingredients:** GEMCITABINE HYDROCHLORIDE
- **Dosage form:** SYSTEM
- **Route:** INTRAVESICAL
- **Marketing status:** Prescription
- **Sponsor:** JANSSEN BIOTECH
- **Manufacturer:** Janssen Biotech, Inc
- **First approval:** 2025-09-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219683)
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