← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2012-09-27
Drug application
- FDA Application #
ANDA079213- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IRBESARTAN
- Generic name
- Irbesartan
- Active ingredients
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZYDUS PHARMS USA INC
- First approval
- 2012-09-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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