FdaApplication
NDA 020758
Identifiers
- fda_app_no: NDA020758
Properties
| Property | Value |
|---|---|
| applicant_name | SANOFI AVENTIS US LLC |
| application_type | NDA |
| approval_date | 1997-09-30 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL |
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL |
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products