Prednisone Delayed Release Oral Tablet

Brand(s)
Rayos
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Horizon Pharma, Inc. (2014-02-12)
Oldest Current Product
2012-07-27
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL TABLET\PREDNISONE
FDAOB
ORAL\TABLET, DELAYED RELEASE\PREDNISONE
SPL Active
ORAL\TABLET, DELAYED RELEASE\PREDNISONE
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\PREDNISONE

product(s) by strength(s)

prednisone 1 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1759870020RayosNDAHorizon Pharma, Inc.2012-07-27PREDNISONEORALTABLET, DELAYED RELEASENDA202020281ab967-7565-4bef-9c0c-a646589c671e

prednisone 2 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1759870021RayosNDAHorizon Pharma, Inc.2012-07-27PREDNISONEORALTABLET, DELAYED RELEASENDA202020281ab967-7565-4bef-9c0c-a646589c671e

prednisone 5 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1759870022RayosNDAHorizon Pharma, Inc.2012-07-27PREDNISONEORALTABLET, DELAYED RELEASENDA202020281ab967-7565-4bef-9c0c-a646589c671e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202020RAYOSHORIZON PHARMA INC2012-07-26p8168218, TREATMENT OF RHEUMATOLOGIC, SUBSTANCE
p8394407, TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1, SUBSTANCE
p8309124, TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1
p6488960, TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF PREDNISONE, SUBSTANCE
p9040085, TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1
p6677326, TREATMENT OF PULMONARY, SUBSTANCE
CLINICAL TRIAL STUDY RESULTS [2015-07-26]NDA202020_001, NDA202020_002, NDA202020_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202020_001RXPREDNISONE (1MG)ORALTABLET, DELAYED RELEASEFalse2012-07-26RAYOS
2NDA202020_002RXPREDNISONE (2MG)ORALTABLET, DELAYED RELEASEFalse2012-07-26RAYOS
3NDA202020_003RXPREDNISONE (5MG)ORALTABLET, DELAYED RELEASETrue2012-07-26RAYOS

patent(s)

#idexpiration dateapplication(s)
1p6488960 (view patent)2020-03-14NDA202020
2p6677326 (view patent)2020-03-14NDA202020
3p8168218 (view patent)2028-01-07NDA202020
4p8309124 (view patent)2024-04-23NDA202020
5p8394407 (view patent)2024-04-23NDA202020
6p9040085 (view patent)2024-04-23NDA202020

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1281ab967-7565-4bef-9c0c-a646589c671e (view SPL)These highlights do not include all the information needed to use RAYOS safely and effectively. See full prescribing information for RAYOS. RAYOS (prednisone) delayed-release tablets 1 mg, 2 mg, 5 mg Initial U.S. Approval: [1955]prescriptionHuman PrescriptionHorizon Pharma, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-02-126759870020, 759870021, 759870022

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII