FdaApplication
ANDA 078629
Identifiers
- fda_app_no: ANDA078629
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA FARMACEUTICA (PORTUGAL) SA |
| application_type | ANDA |
| approval_date | 2009-12-23 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION |
| GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION |
2 products