← FDA Drug Approvals (Drugs@FDA)
AVAPRO
NDA · New Drug Application · Sponsor: SANOFI AVENTIS US · Approved 1997-09-30
Drug application
- FDA Application #
NDA020757
- Application type
- New Drug Application
- Brand name
- AVAPRO
- Generic name
- IRBESARTAN
- Active ingredients
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SANOFI AVENTIS US
- Manufacturer
- Sanofi-Aventis U.S. LLC
- First approval
- 1997-09-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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