mesalamine Extended Release Oral Capsule

Brand(s)
Apriso, Pentasa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Salix Pharmaceuticals, Inc. (2012-04-27)
Oldest Current Product
1993-05-10
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\MESALAMINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\MESALAMINE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\MESALAMINE
ORAL\CAPSULE\MESALAMINE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\MESALAMINE
ORAL\CAPSULE\MESALAMINE

product(s) by strength(s)

mesalamine 250 mg extended release oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1669930410NDAPrasco Laboratories1993-05-10MESALAMINEORALCAPSULENDA0200492c076918-09c0-49bd-bb11-db1e011d597c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551545952PentasaNDACardinal Health1993-05-10MESALAMINEORALCAPSULE540920189NDA02004970adfac7-f8b7-405c-86aa-b1f30343d38b
2681514769PentasaNDACarilion Materials Management1993-05-10MESALAMINEORALCAPSULE540920189NDA020049ec53b1d4-b98d-4b4d-acc3-199f98031966

24 hr mesalamine 375 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490103AprisoNDASalix Pharmaceuticals, Inc.2008-10-31MESALAMINEORALCAPSULE, EXTENDED RELEASENDA0223017951139c-b271-45a4-b523-34b23800917b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686150AprisoNDAPhysicians Total Care, Inc.2010-08-18MESALAMINEORALCAPSULE, EXTENDED RELEASE656490103NDA022301d5d05b1f-9f45-4f66-9f75-3c67934105de

mesalamine 500 mg extended release oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1669930411NDAPrasco Laboratories2004-07-08MESALAMINEORALCAPSULENDA0200492c076918-09c0-49bd-bb11-db1e011d597c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490561PentasaNDARemedyrepack Inc.2011-10-04, 2013-03-19MESALAMINEORALCAPSULE540920191NDA0200491bdf3222-469c-44b0-bbcd-25faeaeff178, e11e41a1-56e3-4505-b3a5-159e03e2daba

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020049PENTASASHIRE DEVELOPMENT INC1993-05-10NDA020049_001, NDA020049_002
2NDA022301APRISOVALEANT PHARMACEUTICALS INTERNATIONAL2008-10-31p8496965, SUBSTANCE
p6551620, FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE AND OLDER, SUBSTANCE
p8956647, SUBSTANCE
p8940328, SUBSTANCE
p8911778, FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS, SUBSTANCE
p8865688, FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
p8337886, FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS, SUBSTANCE
NDA022301_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020049_001RXMESALAMINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalse1993-05-10PENTASA
2NDA020049_002RXMESALAMINE (500MG)ORALCAPSULE, EXTENDED RELEASETrue2004-07-08PENTASA
3NDA022301_001RXMESALAMINE (375MG)ORALCAPSULE, EXTENDED RELEASETrue2008-10-31APRISO

patent(s)

#idexpiration dateapplication(s)
1p6551620 (view patent)2018-04-20NDA022301
2p8337886 (view patent)2018-04-20NDA022301
3p8496965 (view patent)2018-04-20NDA022301
4p8865688 (view patent)2030-05-01NDA022301
5p8911778 (view patent)2018-04-20NDA022301
6p8940328 (view patent)2018-04-20NDA022301
7p8956647 (view patent)2018-04-20NDA022301

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11bdf3222-469c-44b0-bbcd-25faeaeff178 (view SPL)PENTASA(mesalamine)Controlled-Release Capsules 250 mg and 500 mgPrescribing Information as of April 2012Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-191493490561
22c076918-09c0-49bd-bb11-db1e011d597c (view SPL)Mesalamine Controlled-Release CapsulesprescriptionHuman PrescriptionPrasco Laboratoriesmanufacture2010-08-171669930410, 669930411
370adfac7-f8b7-405c-86aa-b1f30343d38b (view SPL)PENTASA (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of August 2010 Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2012-06-264551545952
47951139c-b271-45a4-b523-34b23800917b (view SPL)These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO (mesalamine) extended-release capsules Initial U.S. Approval: 1987prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.MANUFACTURE2012-04-2714656490103
5d5d05b1f-9f45-4f66-9f75-3c67934105de (view SPL)These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO (mesalamine) extended-release capsules Initial U.S. Approval: 1987prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-152548686150
6e11e41a1-56e3-4505-b3a5-159e03e2daba (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-041493490561
7e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606 (view SPL)PENTASA (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of 10/2015 Rx onlyprescriptionHuman PrescriptionShireANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, PARTICLE SIZE REDUCTION2015-10-0921540920189, 540920191
8ec53b1d4-b98d-4b4d-acc3-199f98031966 (view SPL)PENTASA (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of July 2013 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-07-102681514769

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