FDA.reportPublic FDA data

Application 202020

Type
NDA
Sponsor
HORIZON PHARMA USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAYOSPREDNISONETABLET, DELAYED RELEASE;ORAL1MGYesNo
002RAYOSPREDNISONETABLET, DELAYED RELEASE;ORAL2MGYesNo
003RAYOSPREDNISONETABLET, DELAYED RELEASE;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75987-020RAYOSprednisoneHorizon Pharma Inc.NDACurrent
75987-020RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-020RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-020RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-020RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-021RAYOSprednisoneHorizon Pharma Inc.NDACurrent
75987-021RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-021RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-021RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-021RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-022RAYOSprednisoneHorizon Pharma Inc.NDACurrent
75987-022RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-022RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-022RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent
75987-022RAYOSprednisoneHorizon Therapeutics USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78722SUPPL 2024-07-02
78684SUPPL 2024-06-06
61503SUPPL2020-01-02
61476SUPPL2019-12-30
40094SUPPL2013-06-18
32152SUPPL2013-06-18
44839ORIG2013-05-24
22866ORIG2013-05-24
19045ORIG2012-07-30
9942ORIG2012-07-30