FdaApplication
ANDA 210383
Identifiers
- fda_app_no: ANDA210383
Properties
| Property | Value |
|---|---|
| applicant_name | INGENUS PHARMACEUTICALS LLC |
| application_type | ANDA |
| approval_date | 2019-02-14 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION |
3 products