Application 219920
- Type
- NDA
- Sponsor
- AVYXA HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) | Yes | No |
| 002 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) | Yes | Yes |
| 003 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) | Yes | Yes |