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FDA Orange Book · active-ingredient family

Quinapril hydrochloride

Quinapril hydrochloride is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACCUPRIL · NDA 019885

1

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ACCUPRILRLD×4PFIZER PHARMSNDA 019885—Nov 19, 1991

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
QUINAPRIL HYDROCHLORIDE×4PRINSTON INCANDA 205823ABSep 15, 2016
QUINAPRIL HYDROCHLORIDE×4AUROBINDO PHARMA LTDANDA 202725ABApr 29, 2013
QUINAPRIL HYDROCHLORIDE×4SUN PHARM INDS LTDANDA 090800—Jun 18, 2009
QUINAPRIL HYDROCHLORIDE×4ANI PHARMSANDA 075504—Aug 24, 2007
QUINAPRIL HYDROCHLORIDE×4INVAGEN PHARMSANDA 078457—Aug 24, 2007
QUINAPRIL HYDROCHLORIDE×4LUPINANDA 077690ABJun 20, 2006
QUINAPRIL HYDROCHLORIDE×4APOTEX INCANDA 076240—Jan 26, 2006
QUINAPRIL HYDROCHLORIDE×4CHARTWELL RXANDA 076803ABMar 02, 2005
QUINAPRIL HYDROCHLORIDE×4MYLANANDA 076036—Jan 28, 2005
QUINAPRIL HYDROCHLORIDE×4ACTAVIS LABS FL INCANDA 076049—Jan 14, 2005
QUINAPRIL HYDROCHLORIDE×4PHARMOBEDIENTANDA 076694—Dec 23, 2004
QUINAPRIL HYDROCHLORIDE×4ACTAVIS ELIZABETHANDA 076459—Dec 22, 2004
QUINAPRIL HYDROCHLORIDE×4SUN PHARM INDS LTDANDA 076607—Dec 15, 2004

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Quinapril hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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