FdaApplication
NDA 219920
Identifiers
- fda_app_no: NDA219920
Properties
| Property | Value |
|---|---|
| applicant_name | AVYXA HOLDINGS LLC |
| application_type | NDA |
| approval_date | 2025-06-27 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AVGEMSI | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) | SOLUTION;INTRAVENOUS |
| AVGEMSI | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) | SOLUTION;INTRAVENOUS |
| AVGEMSI | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) | SOLUTION;INTRAVENOUS |
3 products