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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 076607


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NDA 076607 describes QUINAPRIL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Lupin, Mylan, Norvium Bioscience, Prinston Inc, Sun Pharm Inds Ltd, Apotex, and Aurobindo Pharma, and is included in nineteen NDAs. It is available from nine suppliers. Additional details are available on the QUINAPRIL HYDROCHLORIDE profile page.

The generic ingredient in QUINAPRIL HYDROCHLORIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 076607
Tradename:QUINAPRIL HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:quinapril hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 15, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 15, 2004TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 15, 2004TE:RLD:No

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