FdaApplication
NDA 020757
Identifiers
- fda_app_no: NDA020757
Properties
| Property | Value |
|---|---|
| applicant_name | SANOFI AVENTIS US LLC |
| application_type | NDA |
| approval_date | 1997-09-30 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AVAPRO | IRBESARTAN | 150MG | TABLET;ORAL |
| AVAPRO | IRBESARTAN | 300MG | TABLET;ORAL |
| AVAPRO | IRBESARTAN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
3 products