FDA.reportPublic FDA data

Application 203634

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UCERISBUDESONIDETABLET, EXTENDED RELEASE;ORAL9MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68012-309UcerisbudesonideSantarus Inc.NDACurrent
68682-309budesonidebudesonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-309budesonidebudesonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-309budesonidebudesonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78723SUPPL 2024-07-02
78661SUPPL 2024-06-06
62560SUPPL2020-04-14
62526SUPPL2020-04-10
45613SUPPL2016-10-17
45548SUPPL2016-10-17
24443ORIG2013-07-08
22930ORIG2013-07-08
32454ORIG2013-01-16
40317ORIG2013-01-15