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AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2015-06-03

Drug application

FDA Application #

ANDA200797

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Generic name

AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Active ingredients

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2015-06-03

Source

Authoritative

Drugs@FDA application overview

Machine

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