← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2016-03-31
Drug application
- FDA Application #
ANDA203630- 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
- Prescription
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- Aurobindo Pharma Limited
- First approval
- 2016-03-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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