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Fuji
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Citi
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US Department of Justice
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Queensland Health

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078457

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NDA 078457 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 078457
Tradename:QUINAPRIL HYDROCHLORIDE
Applicant:Invagen Pharms
Ingredient:quinapril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078457
Suppliers and Packaging for NDA: 078457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 078457 ANDA Camber Pharmaceuticals, Inc. 31722-267 E 31722-267-10
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 078457 ANDA Camber Pharmaceuticals, Inc. 31722-267 E 31722-267-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 24, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 24, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Aug 24, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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Covington
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Colorcon

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