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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090800

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NDA 090800 describes QUINAPRIL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan, Prinston Inc, Sun Pharm Inds Ltd, Teva, Yaopharma Co Ltd, Apotex Corp, and Aurobindo Pharma, and is included in eighteen NDAs. It is available from nineteen 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. Ten suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 090800
Tradename:QUINAPRIL HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:quinapril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090800
Suppliers and Packaging for NDA: 090800
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 090800 ANDA Sun Pharmaceutical Industries Limited 62756-310 E 62756-310-08
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 090800 ANDA Sun Pharmaceutical Industries Limited 62756-310 E 62756-310-18

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jun 18, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jun 18, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jun 18, 2009TE:RLD:No

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