mesalamine Delayed Release Oral Capsule

Brand(s)
Delzicol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Warner Chilcott (Us), Llc (2014-12-11)
Oldest Current Product
2013-03-01
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL CAPSULE\MESALAMINE
FDAOB
ORAL\CAPSULE, DELAYED RELEASE\MESALAMINE
SPL Active
ORAL\CAPSULE, DELAYED RELEASE\MESALAMINE
SPL Moiety
ORAL\CAPSULE, DELAYED RELEASE\MESALAMINE

product(s) by strength(s)

mesalamine 400 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004300753DelzicolNDAWarner Chilcott (Us), Llc2013-03-01MESALAMINEORALCAPSULE, DELAYED RELEASENDA2044128e6b0544-e75d-463a-bd61-517834b49f53

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681515652DelzicolNDACarilion Materials Management2013-03-01MESALAMINEORALCAPSULE, DELAYED RELEASE004300753NDA2044123479cbf1-434e-417f-be73-7c75139013f0

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA204412DELZICOLWARNER CHILCOTT CO LLC2013-02-01p6649180, SUBSTANCENDA204412_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204412_001RXMESALAMINE (400MG)ORALCAPSULE, DELAYED RELEASETrue2013-02-01DELZICOL

patent(s)

#idexpiration dateapplication(s)
1p6649180 (view patent)2020-04-13NDA204412

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13479cbf1-434e-417f-be73-7c75139013f0 (view SPL)These highlights do not include all the information needed to use DELZICOL safely and effectively. See full prescribing information for DELZICOL. DELZICOL (mesalamine) delayed-release capsules, for oral use Initial U.S. Approval: 1987 prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-04-302681515652
28e6b0544-e75d-463a-bd61-517834b49f53 (view SPL)These highlights do not include all the information needed to use DELZICOL safely and effectively. See full prescribing information for DELZICOL. DELZICOL (mesalamine) delayed-release capsules, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionWarner Chilcott (Us), Llc2014-12-1110004300753

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