Quinine Oral Capsule

Brand(s)
Qualaquin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mutual Pharmaceutical Company, Inc. (2015-02-06)
Oldest Current Product
2005-08-12
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\QUININE
FDAOB
ORAL\CAPSULE\QUININE SULFATE
SPL Active
ORAL\CAPSULE\QUININE SULFATE
SPL Moiety
ORAL\CAPSULE\QUININE

product(s) by strength(s)

quinine sulfate 324 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1133100153QualaquinNDAAr Scientific, Inc.2005-08-12QUININE SULFATEORALCAPSULENDA0217991f66fba7-4026-4504-918d-4c88f2835cc0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933002ANDATeva Pharmaceuticals Usa Inc2012-09-28QUININE SULFATEORALCAPSULEANDA091661e782283e-2608-4fd6-a8b2-6c30b9d5d3b0
2003787180ANDAMylan Pharmaceuticals Inc.2012-12-14QUININE SULFATEORALCAPSULEANDA2025812c807aee-de5e-4523-8660-1611712efe7d
3511250201ANDARiconpharma Llc.2015-07-23QUININE SULFATEORALCAPSULEANDA20437258927837-c975-4e51-a7b7-05581b79c23b
4534890700NDA AUTHORIZED GENERICMutual Pharmaceutical Company, Inc.2012-07-23QUININE SULFATEORALCAPSULENDA0217990b5bbefd-5b56-46f9-84f5-1456371577fd
5647200336ANDACorepharma, Llc2015-07-23QUININE SULFATEORALCAPSULEANDA2043724b796723-cb13-4a6e-9719-487e8563190f
6681800560ANDALupin Pharmaceuticals, Inc.2015-08-04QUININE SULFATEORALCAPSULEANDA2031121f32f05c-a215-40be-b951-e41a7b54a8a0

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900595QualaquinNDAStat Rx Usa Llc2005-08-12QUININE SULFATEORALCAPSULE133100153NDA021799ce2ffee3-3048-43a0-ac45-ee32ce0c4c33
2680840947NDA AUTHORIZED GENERICAmerican Health Packaging2015-03-31QUININE SULFATEORALCAPSULE534890700NDA021799274650ff-90b2-4a2c-86a7-906c71b49280

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA091661QUININE SULFATETEVA PHARMACEUTICALS USA2012-09-28ANDA091661_001
2ANDA202581QUININE SULFATEMYLAN PHARMACEUTICALS INC2012-12-14ANDA202581_001
3ANDA203112QUININE SULFATELUPIN LTD2015-04-24ANDA203112_001
4ANDA203729QUININE SULFATEAMNEAL PHARMACEUTICALS2015-07-15ANDA203729_001
5ANDA204372QUININE SULFATERICONPHARMA LLC2015-07-22ANDA204372_001
6NDA021799QUALAQUINMUTUAL PHARMACEUTICAL CO INC2005-08-12NDA021799_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA091661_001RXQUININE SULFATE (324MG)ORALCAPSULEFalseAB2012-09-28QUININE SULFATE
2ANDA202581_001RXQUININE SULFATE (324MG)ORALCAPSULEFalseAB2012-12-14QUININE SULFATE
3ANDA203112_001RXQUININE SULFATE (324MG)ORALCAPSULEFalseAB2015-04-24QUININE SULFATE
4ANDA203729_001RXQUININE SULFATE (324MG)ORALCAPSULEFalseAB2015-07-15QUININE SULFATE
5ANDA204372_001RXQUININE SULFATE (324MG)ORALCAPSULEFalseAB2015-07-22QUININE SULFATE
6NDA021799_001RXQUININE SULFATE (324MG)ORALCAPSULETrueAB2005-08-12QUALAQUIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b5bbefd-5b56-46f9-84f5-1456371577fd (view SPL)These highlights do not include all the information needed to use quinine sulfate capsules, USP safely and effectively. See full prescribing information for quinine sulfate capsules, USP. Quinine Sulfate Capsules, USP for Oral useInitial U.S. Approval: 2005prescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-02-063534890700
21c44c8b7-8b38-4487-a8ba-a94f708d1f50 (view SPL)These highlights do not include all the information needed to use QUALAQUIN safely and effectively. See full prescribing information for QUALAQUIN. QUALAQUIN (quinine sulfate) Capsules, USP for Oral useInitial U.S. Approval: 2005prescriptionHuman PrescriptionCaraco Pharma, Inc.2014-07-232497080153
31f32f05c-a215-40be-b951-e41a7b54a8a0 (view SPL)These highlights do not include all the information needed to use Quinine Sulfate Capsules USP safely and effectively. See full prescribing information for quinine sulfate capsules USP. QUININE Sulfate Capsules, USP for Oral use Initial U.S. Approval: 2005prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture2015-08-074681800560
41f66fba7-4026-4504-918d-4c88f2835cc0 (view SPL)These highlights do not include all the information needed to use QUALAQUIN safely and effectively. See full prescribing information for QUALAQUIN. QUALAQUIN (quinine sulfate) Capsules, USP for Oral useInitial U.S. Approval: 2005 BOXED WARNING (See full prescribing information for complete boxed warning)prescriptionHuman PrescriptionAr Scientific, Inc.2013-04-2316133100153
5274650ff-90b2-4a2c-86a7-906c71b49280 (view SPL)These highlights do not include all the information needed to use quinine sulfate capsules, USP safely and effectively. See full prescribing information for quinine sulfate capsules, USP.Quinine Sulfate Capsules, USP for Oral useInitial U.S. Approval: 2005BOXED WARNING (See full prescribing information for complete boxed warning)prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-142680840947
62c807aee-de5e-4523-8660-1611712efe7d (view SPL)These highlights do not include all the information needed to use quinine sulfate capsules safely and effectively. See full prescribing information for quinine sulfate capsules.QUININE Sulfate Capsules, USP for oral useInitial U.S. Approval: 2005BOXED WARNING (See full prescribing information for complete boxed warning.)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-10-106003787180
74b796723-cb13-4a6e-9719-487e8563190f (view SPL)These highlights do not include all the information needed to use QUININE Sulfate safely and effectively. See full prescribing information for QUININE Sulfate. QUININE Sulfate Capsules, USP for Oral use Initial U.S. Approval: 2005prescriptionHuman PrescriptionCorepharma, Llcmanufacture2015-07-315647200336
858927837-c975-4e51-a7b7-05581b79c23b (view SPL)These highlights do not include all the information needed to use QUININE Sulfate safely and effectively. See full prescribing information for QUININE Sulfate. QUININE Sulfate Capsules, USP for Oral use Initial U.S. Approval: 2005prescriptionHuman PrescriptionRiconpharma Llc.manufacture2015-10-051511250201
9ce2ffee3-3048-43a0-ac45-ee32ce0c4c33 (view SPL)These highlights do not include all the information needed to use QUALAQUIN safely and effectively. See full prescribing information for QUALAQUIN.QUALAQUIN (quinine sulfate) Capsules, USP for Oral useInitial U.S. Approval: 2005BOXED WARNING (See full prescribing information for complete boxed warning)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-03-181165900595
10e782283e-2608-4fd6-a8b2-6c30b9d5d3b0 (view SPL)These highlights do not include all the information needed to use quinine sulfate capsules USP safely and effectively. See full prescribing information for quinine sulfate capsules USP.QUININE sulfate capsules USP for oral use Initial U.S. Approval: 2005prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-305000933002

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII