← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2014-05-09
Drug application
- FDA Application #
ANDA203072- 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
- None (Tentative Approval)
- Sponsor
- PRINSTON INC
- Manufacturer
- Solco Healthcare US, LLC
- First approval
- 2014-05-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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