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AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2017-12-19

Drug application

FDA Application #
ANDA206180
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
AUROBINDO PHARMA
Manufacturer
Aurobindo Pharma Limited
First approval
2017-12-19

Source

Authoritative
Drugs@FDA application overview
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