FdaApplication
ANDA 077545
Identifiers
- fda_app_no: ANDA077545
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA INTERNATIONAL PHARMACEUTICALS LLC |
| application_type | ANDA |
| approval_date | 2007-09-06 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET;ORAL |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL |
3 products