FDA.reportPublic FDA data

Application 021361

Type
NDA
Sponsor
SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XIFAXANRIFAXIMINTABLET;ORAL200MGYesYes
002XIFAXANRIFAXIMINTABLET;ORAL550MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2445XIFAXANrifaximinA-S Medication SolutionsNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal Health 107, LLCNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
55154-6777XIFAXANrifaximinCardinal HealthNDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-301XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
65649-303XIFAXANrifaximinSalix Pharmaceuticals, Inc.NDACurrent
68151-4980XIFAXANrifaximinCarilion Materials ManagementNDACurrent
68258-1107XIFAXANRIFAXIMINDispensing Solutions, Inc.NDACurrent
69189-0309XIFAXANrifaximinAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75907SUPPL 2023-10-24
75880SUPPL 2023-10-20
72445SUPPL2022-10-21
72427SUPPL2022-10-20
65190SUPPL2020-11-12
65175SUPPL2020-11-10
50789SUPPL2017-12-20
50771SUPPL2017-12-19
36761SUPPL2015-05-29
27596SUPPL2015-05-28
5176SUPPL2014-03-14
15303SUPPL2014-03-13
5174SUPPL2010-11-18
15301SUPPL2010-11-17
5175SUPPL2010-03-08
15302SUPPL2010-03-05
27595SUPPL2007-02-12
15300SUPPL2007-02-02
42119ORIG2004-08-27
36760ORIG2004-06-01
5173ORIG2004-06-01