mesalamine Delayed Release Oral Tablet

Brand(s)
Asacol, Lialda
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shire (2014-06-05)
Oldest Current Product
1992-04-01
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL TABLET\MESALAMINE
FDAOB
ORAL\TABLET, DELAYED RELEASE\MESALAMINE
SPL Active
ORAL\TABLET, DELAYED RELEASE\MESALAMINE
ORAL\TABLET\MESALAMINE
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\MESALAMINE
ORAL\TABLET\MESALAMINE

product(s) by strength(s)

mesalamine 1200 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1540920476LialdaNDAShire2007-01-16MESALAMINEORALTABLET, DELAYED RELEASENDA0220003098a080-be86-4265-9818-7fc4beab77b7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790142LialdaNDAKaiser Foundations Hospitals2013-12-06MESALAMINEORALTABLET, DELAYED RELEASE540920476NDA02200007e5ac9c-a5b2-42dc-84fa-963dbc51ba21

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790111AsacolNDAKaiser Foundations Hospitals2012-02-23MESALAMINEORALTABLET, DELAYED RELEASE004300752NDA01965195de7015-932f-48d4-8734-5906aaee697e
2004300752AsacolNDAWarner Chilcott (Us), Llc1992-04-01MESALAMINEORALTABLET, DELAYED RELEASENDA019651d91179bf-48ce-423c-822d-cd06b60caabe
3493490494AsacolNDARemedyrepack Inc.2011-08-17MESALAMINEORALTABLET001490752NDA01965191da40ab-cfd7-4e2a-8ef9-84809176d850
4493490678NDARemedyrepack Inc.2011-03-09MESALAMINEORALTABLET, DELAYED RELEASE001490752NDA01965119ee9e35-356b-4487-be7a-654fe88d8658
5493490951NDARemedyrepack Inc.2012-03-30, 2013-07-29MESALAMINEORALTABLET, DELAYED RELEASE004300752NDA019651b3885d2c-8318-4aca-9b9c-c5a5ee847ed0, ef12dce1-5259-40bf-84f3-2db4859c560b
6499990969AsacolNDALake Erie Medical Dba Quality Care Products Llc2012-03-23MESALAMINEORALTABLET, DELAYED RELEASE004300752NDA01965124998e63-f01e-4a07-be5b-203aadd46941
7538080205AsacolNDAState Of Florida Doh Central Pharmacy2009-07-01MESALAMINEORALTABLET, DELAYED RELEASE001490752NDA01965183864c82-9114-4523-bab8-2b47beb88d4e
8538080823AsacolNDAState Of Florida Doh Central Pharmacy2013-01-01MESALAMINEORALTABLET, DELAYED RELEASE004300752NDA019651a97c3815-a0d5-4763-8c3f-9caa5dd9b01b
9551542305AsacolNDACardinal Health1992-04-01MESALAMINEORALTABLET, DELAYED RELEASE001490752NDA019651d31a6e7d-31b1-474e-bc7b-821b08115109
10551548607AsacolNDACardinal Health1992-04-01MESALAMINEORALTABLET, DELAYED RELEASE004300752NDA019651ac724f97-5941-47c1-bcc9-eb5e64be815a

mesalamine 800 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004300783AsacolNDAWarner Chilcott (Us), Llc2008-05-28MESALAMINEORALTABLET, DELAYED RELEASENDA02183003a3bff5-e652-4771-9bf7-3b6850423cc5

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1NDA019651ASACOLTrueWARNER CHILCOTT CO LLC1992-01-31NDA019651_001
2NDA021830ASACOL HDWARNER CHILCOTT CO LLC2008-05-29p9089492, SUBSTANCE
p6893662, TREATMENT OF ULCERATIVE COLITIS, SUBSTANCE
p8580302, SUBSTANCE
NDA021830_001
3NDA022000LIALDASHIRE DEVELOPMENT INC2007-01-16p6773720, SUBSTANCEMAINTENANCE OF REMISSION OF ULCERATIVE COLITIS [2014-07-14]NDA022000_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA019651_001discontinuedMESALAMINE (400MG)ORALTABLET, DELAYED RELEASEFalse1992-01-31ASACOL
2NDA021830_001RXMESALAMINE (800MG)ORALTABLET, DELAYED RELEASETrue2008-05-29ASACOL HD
3NDA022000_001RXMESALAMINE (1.2GM)ORALTABLET, DELAYED RELEASETrue2007-01-16LIALDA

patent(s)

#idexpiration dateapplication(s)
1p6773720 (view patent)2020-06-08NDA022000
2p6893662 (view patent)2021-11-15NDA021830
3p8580302 (view patent)2021-11-15NDA021830
4p9089492 (view patent)2021-11-15NDA021830

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103a3bff5-e652-4771-9bf7-3b6850423cc5 (view SPL)These highlights do not include all the information needed to use ASACOL HD safely and effectively. See full prescribing information for ASACOL HD. ASACOL HD ( m esala m ine) delayed-release tablets, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionWarner Chilcott (Us), LlcANALYSIS, MANUFACTURE2013-10-015004300783
207e5ac9c-a5b2-42dc-84fa-963dbc51ba21 (view SPL)These highlights do not include all the information needed to use LIALDA safely and effectively. See full prescribing information for LIALDA. LIALDA (mesalamine) delayed-release tablets, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2013-12-061001790142
319ee9e35-356b-4487-be7a-654fe88d8658 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-03-091493490678
424998e63-f01e-4a07-be5b-203aadd46941 (view SPL)Asacol (mesalamine)Delayed-Release TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-233702499990969
53098a080-be86-4265-9818-7fc4beab77b7 (view SPL)These highlights do not include all the information needed to use LIALDA safely and effectively. See full prescribing information for LIALDA. LIALDA (mesalamine) delayed-release tablets, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionShireANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-06-0526540920476
683864c82-9114-4523-bab8-2b47beb88d4e (view SPL)Asacol (mesalamine)Delayed-Release TabletsprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-03-122538080205
791da40ab-cfd7-4e2a-8ef9-84809176d850 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-172493490494
895de7015-932f-48d4-8734-5906aaee697e (view SPL)Asacol (mesalamine)Delayed-Release TabletsprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-02-241001790111
9a97c3815-a0d5-4763-8c3f-9caa5dd9b01b (view SPL)Asacol (mesalamine)Delayed-Release TabletsprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-03-072538080823
10ac724f97-5941-47c1-bcc9-eb5e64be815a (view SPL)Asacol (mesalamine)Delayed-Release TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2015-04-283551548607
11b3885d2c-8318-4aca-9b9c-c5a5ee847ed0 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-07-292493490951
12d31a6e7d-31b1-474e-bc7b-821b08115109 (view SPL)Asacol (mesalamine)Delayed-Release TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2011-10-063551542305
13d91179bf-48ce-423c-822d-cd06b60caabe (view SPL)These highlights do not include all the information needed to use ASACOL safely and effectively. See full prescribing information for ASACOL. ASACOL (mesalamine) delayed-release tablets, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionWarner Chilcott (Us), Llc2015-05-276004300752
14ef12dce1-5259-40bf-84f3-2db4859c560b (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-301493490951

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