FdaApplication
ANDA 213175
Identifiers
- fda_app_no: ANDA213175
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA PHARMACEUTICALS INTERNATIONAL LTD |
| application_type | ANDA |
| approval_date | 2023-03-07 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION |
3 products