FDA.reportPublic FDA data

Application 020675

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001URSO 250URSODIOLTABLET;ORAL250MGYesNo
002URSO FORTEURSODIOLTABLET;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2998UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2998UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2998UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3005UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3005UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3005UrsodiolUrsodiolActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
58914-785Urso 250UrsodiolAllergan, Inc.NDACurrent
58914-785Urso 250UrsodiolAllergan, Inc.NDACurrent
58914-785Urso 250UrsodiolAllergan, Inc.NDACurrent
58914-785Urso 250UrsodiolAllergan, Inc.NDACurrent
58914-785Urso 250UrsodiolAllergan, Inc.NDACurrent
58914-790Urso ForteUrsodiolAllergan, Inc.NDACurrent
58914-790Urso ForteUrsodiolAllergan, Inc.NDACurrent
58914-790Urso ForteUrsodiolAllergan, Inc.NDACurrent
58914-790Urso ForteUrsodiolAllergan, Inc.NDACurrent
58914-790Urso ForteUrsodiolAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73156SUPPL2023-01-13
73154SUPPL2023-01-13
67454SUPPL2021-05-12
67450SUPPL2021-05-11
35124SUPPL2013-06-18
25492SUPPL2013-06-18
13185SUPPL2009-12-02
13184SUPPL2008-03-13
3059SUPPL2008-03-13
25491SUPPL2004-09-29
35123SUPPL2004-07-28
25490SUPPL2004-07-28
25489SUPPL2001-03-08
3058SUPPL2001-03-08
20814ORIG1997-12-10