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Serving leading biopharmaceutical companies globally:

Covington
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US Department of Justice
UBS
Federal Trade Commission
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205823

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NDA 205823 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-one 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 205823
Tradename:QUINAPRIL HYDROCHLORIDE
Applicant:Prinston Inc
Ingredient:quinapril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205823
Suppliers and Packaging for NDA: 205823
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 205823 ANDA Solco Healthcare US, LLC 43547-410 N 43547-410-09
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 205823 ANDA Solco Healthcare US, LLC 43547-411 N 43547-411-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 15, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 15, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 15, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
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Covington
Fuji
Harvard Business School
Mallinckrodt
McKinsey

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