Budesonide Delayed Release Oral Capsule

Brand(s)
Entocort
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2011-12-20)
Oldest Current Product
2001-10-29
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
DELAYED RELEASE ORAL CAPSULE\BUDESONIDE
FDAOB
ORAL\CAPSULE\BUDESONIDE
SPL Active
ORAL\CAPSULE\BUDESONIDE
SPL Moiety
ORAL\CAPSULE\BUDESONIDE

product(s) by strength(s)

budesonide 3 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1654830702EntocortNDAPrometheus Laboratories Inc.2001-10-29BUDESONIDEORALCAPSULENDA021324fe6530ef-1b23-451f-1290-0e3ef02ec1b5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787155ANDAMylan Pharmaceuticals Inc.2013-08-23BUDESONIDEORALCAPSULEANDA0904104a578d93-087e-42f7-a258-a49afef41dea
2498840501NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2011-08-18BUDESONIDEORALCAPSULENDA0213245c73928d-2b96-42f5-1fb9-90965c214c21

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790020ANDAMylan Institutional Inc.2011-09-02BUDESONIDEORALCAPSULE003787155ANDA090410d361c2ed-99e8-4089-bbba-cbcf2b239228
2548684910EntocortNDAPhysicians Total Care, Inc.2006-05-22BUDESONIDEORALCAPSULE654830702NDA02132498a4eca1-904c-4355-957a-b5a141573cc2
3604290264ANDAGolden State Medical Supply, Inc.2015-07-10BUDESONIDEORALCAPSULE003787155ANDA0904105868e960-73ca-4219-b122-11893dedfdcf
4681514374ANDACarilion Materials Management2013-08-23BUDESONIDEORALCAPSULE003787155ANDA0904107633c9b3-dfb5-446f-a260-e44b6e48afa2

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA090379BUDESONIDEBARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA2014-04-02ANDA090379_001
2ANDA090410BUDESONIDEMYLAN PHARMACEUTICALS INC2011-05-16ANDA090410_001
3NDA021324ENTOCORT ECASTRAZENECA LP2001-10-02p5643602, TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHSNDA021324_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090379_001RXBUDESONIDE (3MG)ORALCAPSULEFalseAB2014-04-02BUDESONIDE
2ANDA090410_001RXBUDESONIDE (3MG)ORALCAPSULEFalseAB2011-05-16BUDESONIDE
3NDA021324_001RXBUDESONIDE (3MG)ORALCAPSULETrueAB2001-10-02ENTOCORT EC

patent(s)

#idexpiration dateapplication(s)
1p5643602 (view patent)2014-07-01NDA021324

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14a578d93-087e-42f7-a258-a49afef41dea (view SPL)These highlights do not include all the information needed to use budesonide capsules (enteric coated) safely and effectively. See full prescribing information for budesonide capsules (enteric coated). BUDESONIDE capsules (enteric coated), for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-03-053003787155
25868e960-73ca-4219-b122-11893dedfdcf (view SPL)These highlights do not include all the information needed to use budesonide capsules (enteric coated) safely and effectively. See full prescribing information for budesonide capsules (enteric coated).BUDESONIDE capsules (enteric coated), for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-10-141604290264
35c73928d-2b96-42f5-1fb9-90965c214c21 (view SPL)These highlights do not include all the information needed to use budesonide safely and effectively. See full prescribing information for budesonide.Budesonide Capsules, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2011-12-207498840501
470532afa-4006-4883-feb2-927faaee8e20 (view SPL)These highlights do not include all the information needed to use ENTOCORT EC safely and effectively. See full prescribing information for ENTOCORT EC. ENTICORT EC (budesonide) capsules, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionAstrazeneca LpMANUFACTURE2011-12-275001860702
57633c9b3-dfb5-446f-a260-e44b6e48afa2 (view SPL)These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1997 budesonide capsules (enteric coated) budesonide capsules (enteric coated) BUDESONIDE capsules (enteric coated), for oral useprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-03-052681514374
698a4eca1-904c-4355-957a-b5a141573cc2 (view SPL)ENTOCORT EC (budesonide) CAPSULESprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-072548684910
7d361c2ed-99e8-4089-bbba-cbcf2b239228 (view SPL)These highlights do not include all the information needed to use budesonide capsules (enteric coated) safely and effectively. See full prescribing information for budesonide capsules (enteric coated).BUDESONIDE capsules (enteric coated), for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Institutional Inc.2015-07-032510790020
8fe6530ef-1b23-451f-1290-0e3ef02ec1b5 (view SPL)ENTOCORT EC (budesonide) CAPSULESprescriptionHuman PrescriptionPrometheus Laboratories Inc.API MANUFACTURE, MANUFACTURE2009-06-246654830702

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