You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078457


✉ Email this page to a colleague

« Back to Dashboard


NDA 078457 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 078457
Tradename:QUINAPRIL HYDROCHLORIDE
Applicant:Invagen Pharms
Ingredient:quinapril hydrochloride
Patents:0
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 Proficient Rx LP 63187-425 63187-425-30 30 TABLET in 1 BOTTLE (63187-425-30)
QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 078457 ANDA Proficient Rx LP 63187-425 63187-425-60 60 TABLET in 1 BOTTLE (63187-425-60)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.