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ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TARO PHARM INDS · Approved 2001-09-18

Drug application

FDA Application #

ANDA075788

Application type

Abbreviated New Drug Application (Generic)

Brand name

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

Generic name

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

Active ingredients

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

TARO PHARM INDS

Manufacturer

Taro Pharmaceuticals U.S.A., Inc.

First approval

2001-09-18

Source

Authoritative

Drugs@FDA application overview

Machine

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