FdaApplication
NDA 219683
Identifiers
- fda_app_no: NDA219683
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN BIOTECH INC |
| application_type | NDA |
| approval_date | 2025-09-09 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| INLEXZO | GEMCITABINE HYDROCHLORIDE | EQ 225MG BASE | SYSTEM;INTRAVESICAL |
1 product