approval · primary record
GEMCITABINE HYDROCHLORIDE
FDA · NDA · 2025-09-09
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Action date | 2025-09-09 |
| Brand | INLEXZO |
| Sponsor | JANSSEN BIOTECH |
| Route | INTRAVESICAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-28T02:35:40.508Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: FDA:GEMCITABINE HYDROCHLORIDE:2025-09-09
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