FDA.reportPublic FDA data

Application 021799

Type
NDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUALAQUINQUININE SULFATECAPSULE;ORAL324MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13310-153QualaquinQuinine SulfateAR Scientific Inc.NDACurrent
49708-153QualaquinQuinine SulfateSun Pharmaceutical Industries, Inc.NDACurrent
49708-153QualaquinQuinine SulfateSun Pharmaceutical Industries, Inc.NDACurrent
53489-700Quinine SulfateQuinine SulfateSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
53489-700Quinine SulfateQuinine SulfateSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
53489-700Quinine SulfateQuinine SulfateSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
68084-947Quinine SulfateQuinine SulfateAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-947Quinine SulfateQuinine SulfateAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-947Quinine SulfateQuinine SulfateAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-947Quinine SulfateQuinine SulfateAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
71557-047QualaquinQuinine SulfateFrontida BioPharm, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59133SUPPL2019-06-20
59128SUPPL2019-06-20
59127SUPPL2019-06-20
28626SUPPL2014-07-03
16397SUPPL2014-07-03
37676SUPPL2013-04-16
28625SUPPL2013-04-16
37675SUPPL2013-02-26
6220SUPPL2013-02-26
6221SUPPL2012-05-24
28624SUPPL2011-04-19
16396SUPPL2011-04-18
16395SUPPL2010-06-24
6217SUPPL2010-06-17
6219SUPPL2010-01-29
6218SUPPL2010-01-25
28623SUPPL2009-12-31
43782ORIG2009-12-03
37674SUPPL2009-11-23
6216SUPPL2008-11-18
16394SUPPL2008-11-17
42317ORIG2008-07-09
16393SUPPL2007-10-10
6215SUPPL2007-10-04
28622ORIG2005-08-16
16392ORIG2005-08-15