FDA.reportPublic FDA data

Application 019594

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTIGALLURSODIOLCAPSULE;ORAL150MGNoNo
002ACTIGALLURSODIOLCAPSULE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6145ActigallUrsodiolAllergan, Inc.NDACurrent
0023-6145ActigallUrsodiolAllergan, Inc.NDACurrent
0591-3159UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3159UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3159UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3159UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0615-1374UrsodiolUrsodiolNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
52544-930ActigallUrsodiolActavis Pharma, Inc.NDACurrent
68151-2987UrsodiolUrsodiolCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68788-6807UrsodiolUrsodiolPreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74841SUPPL 2023-07-20
74802SUPPL 2023-07-20
51025SUPPL2018-01-11
1405SUPPL2002-08-14