mesalamine Rectal Suppository

Brand(s)
Canasa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aptalis Pharma Inc. (2015-06-16)
Oldest Current Product
2001-01-05
License(s)
NDA
RxNORM
RECTAL SUPPOSITORY\MESALAMINE
FDAOB
RECTAL\SUPPOSITORY\MESALAMINE
SPL Active
RECTAL\SUPPOSITORY\MESALAMINE
SPL Moiety
RECTAL\SUPPOSITORY\MESALAMINE

product(s) by strength(s)

mesalamine 1000 mg rectal suppository

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1589140501CanasaNDAAptalis Pharma Inc.2001-01-05MESALAMINERECTALSUPPOSITORYNDA02125289d91601-152b-4398-bebe-af1c023e9935

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686147CanasaNDAPhysicians Total Care, Inc.2010-08-18MESALAMINERECTALSUPPOSITORY58914050156NDA021252357e0e6b-cfbd-454c-82d7-cfc460dc0d68

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA019919ROWASATrueMEDA PHARMACEUTICALS INC1990-12-18NDA019919_001
2NDA021252CANASAFOREST LABORATORIES LLC2001-01-05p8436051, SUBSTANCE
p8217083, SUBSTANCE
NDA021252_001, NDA021252_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA019919_001discontinuedMESALAMINE (500MG)RECTALSUPPOSITORYFalse1990-12-18ROWASA
2NDA021252_001discontinuedMESALAMINE (500MG)RECTALSUPPOSITORYFalse2001-01-05CANASA
3NDA021252_002RXMESALAMINE (1GM)RECTALSUPPOSITORYTrue2004-11-05CANASA

patent(s)

#idexpiration dateapplication(s)
1p8217083 (view patent)2028-06-06NDA021252
2p8436051 (view patent)2028-06-06NDA021252

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1357e0e6b-cfbd-454c-82d7-cfc460dc0d68 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-08-231548686147
289d91601-152b-4398-bebe-af1c023e9935 (view SPL)These highlights do not include all the information needed to use CANASA safely and effectively. See full prescribing information for CANASA. CANASA (mesalamine) rectal suppository. Initial U.S. Approval: 1987prescriptionHuman PrescriptionAptalis Pharma Inc.MANUFACTURE2015-06-169589140501

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