← FDA Drug Approvals (Drugs@FDA)
INLEXZO
NDA · New Drug Application · Sponsor: JANSSEN BIOTECH · Approved 2025-09-09
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown