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AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2012-09-05

Drug application

FDA Application #

ANDA202239

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Generic name

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE

Active ingredients

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA LTD

Manufacturer

Rising Pharma Holdings, Inc.

First approval

2012-09-05

Source

Authoritative

Drugs@FDA application overview

Machine

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