FdaApplication
ANDA 078403
Identifiers
- fda_app_no: ANDA078403
Properties
| Property | Value |
|---|---|
| applicant_name | GRANULES INDIA LTD |
| application_type | ANDA |
| approval_date | 2008-01-08 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL |
3 products