FDA.reportPublic FDA data

Application 020573

Type
NDA
Sponsor
HORIZON THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPHENYLSODIUM PHENYLBUTYRATEPOWDER;ORAL3GM/TEASPOONFULYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75987-070Buphenylsodium phenylbutyrateHorizon Therapeutics USA, Inc.NDACurrent
75987-070Buphenylsodium phenylbutyrateHorizon Therapeutics USA, Inc.NDACurrent
75987-070Buphenylsodium phenylbutyrateHorizon Therapeutics USA, Inc.NDACurrent
75987-070Buphenylsodium phenylbutyrateHorizon Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71696SUPPL2022-08-02
71670SUPPL2022-08-01
57665ORIG2019-02-15
25215SUPPL2009-04-03
12758SUPPL2009-04-03