FdaApplication
ANDA 201505
Identifiers
- fda_app_no: ANDA201505
Properties
| Property | Value |
|---|---|
| applicant_name | APOTEX INC |
| application_type | ANDA |
| approval_date | 2012-10-15 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL |
| IRBESARTAN HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;300MG | TABLET;ORAL |
3 products