← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2011-02-16
Drug application
- FDA Application #
ANDA090815- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IRBESARTAN; HYDROCHLOROTHIAZIDE
- Generic name
- Irbesartan
- Active ingredients
- IRBESARTAN; HYDROCHLOROTHIAZIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ZYDUS PHARMS USA INC
- First approval
- 2011-02-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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