Budesonide Extended Release Oral Tablet

Brand(s)
Uceris
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Santarus, Inc. (2015-01-26)
Oldest Current Product
2013-01-14
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\BUDESONIDE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\BUDESONIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\BUDESONIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\BUDESONIDE

product(s) by strength(s)

24 hr budesonide 9 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1680120309UcerisNDASantarus, Inc.2013-01-14BUDESONIDEORALTABLET, EXTENDED RELEASENDA20363492cbb190-8851-46ed-bfe0-166ca62ef2e9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203634UCERISVALEANT PHARMACEUTICALS INTERNATIONAL2013-01-14p8784888, SUBSTANCE
p8293273, SUBSTANCE
p8895064, SUBSTANCE
pRE43799, INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, SUBSTANCE
p7410651, INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, SUBSTANCE
p7431943, SUBSTANCE
p9132093, SUBSTANCE
NEW DOSAGE FORM [2016-01-14]NDA203634_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203634_001RXBUDESONIDE (9MG)ORALTABLET, EXTENDED RELEASETrue2013-01-14UCERIS

patent(s)

#idexpiration dateapplication(s)
1p7410651 (view patent)2020-06-09NDA203634
2p7431943 (view patent)2020-06-09NDA203634
3p8293273 (view patent)2020-06-09NDA203634
4p8784888 (view patent)2020-06-09NDA203634
5p8895064 (view patent)2031-09-07NDA203634
6p9132093 (view patent)2031-09-07NDA203634
7pRE43799 (view patent)2020-06-09NDA203634

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
192cbb190-8851-46ed-bfe0-166ca62ef2e9 (view SPL)These highlights do not include all the information needed to useUCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS(budesonide)tablet fororal use Initial U.S. Approval: 1997prescriptionHuman PrescriptionSantarus, Inc.2015-01-2611680120309

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