FdaApplication
ANDA 201524
Identifiers
- fda_app_no: ANDA201524
Properties
| Property | Value |
|---|---|
| applicant_name | CHARTWELL RX SCIENCES LLC |
| application_type | ANDA |
| approval_date | 2013-02-27 |
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 | IRBESARTAN; HYDROCHLOROTHIAZIDE | 300MG;25MG | TABLET;ORAL |
3 products