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FDA Orange Book · active-ingredient family

Quinidine gluconate

Quinidine gluconate is approved as 3 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:QUINIDINE GLUCONATE · NDA 007529

3

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
QUINIDINE GLUCONATERLDLILLYNDA 007529—Feb 10, 1989
QUINAGLUTERLDBAYER HLTHCARENDA 016647—Approved Prior to Jan 1, 1982
DURAQUINWARNER CHILCOTTNDA 017917—Approved Prior to Jan 1, 1982

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
QUINIDINE GLUCONATEHIBROW HLTHCAREANDA 212589ABSep 17, 2021
QUINIDINE GLUCONATERISINGANDA 089894—Dec 15, 1988
QUINIDINE GLUCONATEHALSEYANDA 089476—Apr 10, 1987
QUINIDINE GLUCONATESUN PHARM INDUSTRIESANDA 089338ABFeb 11, 1987
QUINALANCHARTWELL MOLECULARANDA 088081—Feb 10, 1986
QUINIDINE GLUCONATESUPERPHARMANDA 089164—Nov 21, 1985
QUINIDINE GLUCONATEASCOTANDA 088582—Jun 17, 1985
QUINIDINE GLUCONATECYCLEANDA 088431—Jan 06, 1984
QUINIDINE GLUCONATEWATSON LABSANDA 087785—Jan 24, 1983
QUINIDINE GLUCONATEANI PHARMSANDA 087810—Sep 29, 1982
QUINATIMEWATSON LABSANDA 087448—Approved Prior to Jan 1, 1982
QUINACTBAYER HLTHCAREANDA 085978—Approved Prior to Jan 1, 1982
QUINACTBAYER HLTHCAREANDA 086099—Approved Prior to Jan 1, 1982

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.

Quinidine gluconate — frequently asked questions

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

Agent CTA Background

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