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IRBESARTAN AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ · Approved 2012-09-27

Drug application

FDA Application #
ANDA077446
Application type
Abbreviated New Drug Application (Generic)
Brand name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Generic name
Hydrochlorothiazide
Active ingredients
HYDROCHLOROTHIAZIDE; IRBESARTAN
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
SANDOZ
First approval
2012-09-27

Source

Authoritative
Drugs@FDA application overview
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