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IRBESARTAN AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2017-06-08

Drug application

FDA Application #

ANDA090351

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

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2017-06-08

Source

Authoritative

Drugs@FDA application overview

Machine

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