FDA.reportPublic FDA data

Application 020572

Type
NDA
Sponsor
HORIZON THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPHENYLSODIUM PHENYLBUTYRATETABLET;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75987-060BUPHENYLsodium phenylbutyrateHorizon Therapeutics USA, Inc.NDACurrent
75987-060BUPHENYLsodium phenylbutyrateHorizon Therapeutics USA, Inc.NDACurrent
75987-060BUPHENYLsodium phenylbutyrateHorizon Therapeutics USA, Inc.NDACurrent
75987-060BUPHENYLsodium phenylbutyrateHorizon Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71695SUPPL2022-08-02
71669SUPPL2022-08-01
25214SUPPL2009-04-03
12757SUPPL2009-04-03