← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA · Approved 2012-03-30
Drug application
- FDA Application #
ANDA077369- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Generic name
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Active ingredients
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- TEVA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- First approval
- 2012-03-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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