Assyro AI

FDA Orange Book · active-ingredient family

Quinidine sulfate

Quinidine sulfate is approved as 1 brand and 47 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:QUINIDEX · NDA 012796

1

Brand (NDA)

47

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

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

ProductApplicantApplicationTEApproved
QUINIDEXWYETH PHARMS INCNDA 012796Approved Prior to Jan 1, 1982

Generic (ANDA) products (47)

ProductApplicantApplicationTEApproved
QUINIDINE SULFATECOSETTEANDA 040045Jun 30, 1994
QUINIDINE SULFATESUN PHARM INDUSTRIESANDA 081029Apr 14, 1989
QUINIDINE SULFATESUN PHARM INDUSTRIESANDA 081030Apr 14, 1989
QUINIDINE SULFATESUN PHARM INDUSTRIESANDA 081031Apr 14, 1989
QUINIDINE SULFATECHARTWELL RXANDA 089839Sep 29, 1988
QUINIDINE SULFATESUPERPHARMANDA 088973Apr 10, 1985
QUINIDINE SULFATEVANGARDANDA 087909Jul 13, 1982
QUINIDINE SULFATEUSL PHARMAANDA 087837Apr 14, 1982
CIN-QUINSOLVAYANDA 085296Approved Prior to Jan 1, 1982
CIN-QUINSOLVAYANDA 085297Approved Prior to Jan 1, 1982
QUINIDINE SULFATELILLYANDA 085103Approved Prior to Jan 1, 1982
CIN-QUINRLDSOLVAYANDA 085299Approved Prior to Jan 1, 1982
CIN-QUINRLDSOLVAYANDA 084932Approved Prior to Jan 1, 1982
CIN-QUINSOLVAYANDA 085298Approved Prior to Jan 1, 1982
QUINIDINE SULFATEBARRANDA 084177Approved Prior to Jan 1, 1982
QUINIDINE SULFATECHARTWELL MOLECULARANDA 083743Approved Prior to Jan 1, 1982
QUINIDINE SULFATECONTRACT PHARMACALANDA 083808Approved Prior to Jan 1, 1982
QUINIDINE SULFATECYCLEANDA 083640Approved Prior to Jan 1, 1982
QUINIDINE SULFATECYCLEANDA 085632Approved Prior to Jan 1, 1982
QUINIDINE SULFATEDAVA PHARMS INCANDA 087011Approved Prior to Jan 1, 1982
QUINIDINE SULFATEELKINS SINNANDA 083622Approved Prior to Jan 1, 1982
QUINIDINE SULFATE×2EPIC PHARMA LLCANDA 088072Approved Prior to Jan 1, 1982
QUINIDINE SULFATEEVERYLIFEANDA 083439Approved Prior to Jan 1, 1982
QUINIDINE SULFATEHALSEYANDA 083583Approved Prior to Jan 1, 1982
QUINIDINE SULFATEHIKMAANDA 083862Approved Prior to Jan 1, 1982
QUINIDINE SULFATEIMPAX LABSANDA 083347Approved Prior to Jan 1, 1982
QUINIDINE SULFATEIVAX SUB TEVA PHARMSANDA 084549Approved Prior to Jan 1, 1982
QUINIDINE SULFATEKING PHARMSANDA 085175Approved Prior to Jan 1, 1982
QUINIDINE SULFATEKV PHARMANDA 085276Approved Prior to Jan 1, 1982
QUINIDINE SULFATELEDERLEANDA 086176Approved Prior to Jan 1, 1982
QUINIDINE SULFATELILLYANDA 085038Approved Prior to Jan 1, 1982
QUINIDINE SULFATEPERRIGOANDA 085322Approved Prior to Jan 1, 1982
QUINIDINE SULFATEPHARMAVITEANDA 084627Approved Prior to Jan 1, 1982
QUINIDINE SULFATEPUREPAC PHARMANDA 084003Approved Prior to Jan 1, 1982
QUINIDINE SULFATESANDOZANDA 084631Approved Prior to Jan 1, 1982
QUINIDINE SULFATESANDOZANDA 084914Approved Prior to Jan 1, 1982
QUINIDINE SULFATESCHERER LABSANDA 085068Approved Prior to Jan 1, 1982
QUINIDINE SULFATEVALEANT PHARM INTLANDA 083393Approved Prior to Jan 1, 1982
QUINIDINE SULFATEVINTAGE PHARMSANDA 083963Approved Prior to Jan 1, 1982
QUINIDINE SULFATEWARNER CHILCOTTANDA 083879Approved Prior to Jan 1, 1982
QUINIDINE SULFATEWATSON LABSANDA 085584Approved Prior to Jan 1, 1982
QUINIDINE SULFATEWATSON LABSANDA 083288Approved Prior to Jan 1, 1982
QUINIDINE SULFATEWATSON LABSANDA 085140Approved Prior to Jan 1, 1982
QUINIDINE SULFATEWATSON LABSANDA 085583Approved Prior to Jan 1, 1982
QUINIDINE SULFATEWHITEWORTH TOWN PLSNANDA 085444Approved Prior to Jan 1, 1982
QUINORAKEY PHARMSANDA 083576Approved Prior to Jan 1, 1982
QUINORARLDSCHERINGANDA 085222Approved 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 sulfate — 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.