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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 076803


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NDA 076803 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, Prinston Inc, Sun Pharm Inds Ltd, Apotex, and Aurobindo Pharma, and is included in nineteen NDAs. It is available from eleven 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. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 076803
Tradename:QUINAPRIL HYDROCHLORIDE
Applicant:Chartwell Rx
Ingredient:quinapril hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076803
Suppliers and Packaging for NDA: 076803
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076803 ANDA Chartwell RX, LLC 62135-484 62135-484-60 60 TABLET, FILM COATED in 1 BOTTLE (62135-484-60)
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076803 ANDA Chartwell RX, LLC 62135-485 62135-485-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-485-90)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Mar 2, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 2, 2005TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 2, 2005TE:RLD:No

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