Application 201505
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;150MG | No | No |
| 002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;300MG | No | No |
| 003 | IRBESARTAN HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET; ORAL | 25MG;300MG | No | No |