mesalamine Enema

Brand(s)
Rowasa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alaven Pharmaceutical (2013-05-08)
Oldest Current Product
1988-01-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ENEMA\MESALAMINE
FDAOB
RECTAL\ENEMA\MESALAMINE
SPL Active
RECTAL\ENEMA\MESALAMINE
RECTAL\SUSPENSION\MESALAMINE
SPL Moiety
RECTAL\ENEMA\MESALAMINE
RECTAL\SUSPENSION\MESALAMINE

product(s) by strength(s)

mesalamine 66.7 mg/ml enema

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433860510NDAGavis Pharmaceuticals, Llc2009-12-16MESALAMINERECTALENEMANDA019618dfeede98-5520-4fd1-be02-4971453f9e24
2682200066RowasaNDAAlaven Pharmaceutical1988-01-31MESALAMINERECTALENEMANDA0196182f393841-42ef-46a4-a7b0-21cc59815912

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1458020098ANDAPerrigo New York Inc2007-10-11MESALAMINERECTALENEMAANDA076751a4ddf68d-1502-4242-89aa-c96436bdcbf6
2458020923ANDAPerrigo New York Inc2009-09-01, 2010-02-17ANDA076751d50f2c37-5675-49f3-bdd4-3b16d333ed40, eb5bcaab-0f86-4817-9373-0a5e5e1982d2
3505320066NDA AUTHORIZED GENERICFranklin Pharmaceutical Llc2010-04-01MESALAMINERECTALSUSPENSIONNDA019618743ada1c-0f04-43ea-be7d-1560164e6f6e

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076751MESALAMINEPERRIGO ISRAEL PHARMACEUTICALS LTD2004-09-17ANDA076751_001
2ANDA076841MESALAMINEG AND W LABORATORIES INC2004-09-30ANDA076841_001
3NDA019618ROWASAMEDA PHARMACEUTICALS INC1987-12-24p7645801, SUBSTANCENDA019618_001, NDA019618_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076751_001RXMESALAMINE (4GM/60ML)RECTALENEMAFalseAB2004-09-17MESALAMINE
2ANDA076841_001RXMESALAMINE (4GM/60ML)RECTALENEMAFalseAB2004-09-30MESALAMINE
3NDA019618_001RXMESALAMINE (4GM/60ML)RECTALENEMATrueAB1987-12-24ROWASA
4NDA019618_002RXMESALAMINE (4GM/60ML)RECTALENEMAFalseAB2008-06-20ROWASA

patent(s)

#idexpiration dateapplication(s)
1p7645801 (view patent)2027-07-24NDA019618

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12f393841-42ef-46a4-a7b0-21cc59815912 (view SPL)ROWASA(mesalamine)Rectal Suspension Enema4.0 grams/unit (60 mL)Rx onlyprescriptionHuman PrescriptionAlaven Pharmaceutical2013-05-081682200066
2743ada1c-0f04-43ea-be7d-1560164e6f6e (view SPL)Mesalamine Rectal Suspension Enema 4 grams/unit (60 mL)prescriptionHuman PrescriptionFranklin Pharmaceutical LlcANALYSIS, MANUFACTURE2012-10-312505320066
3a4ddf68d-1502-4242-89aa-c96436bdcbf6 (view SPL)Mesalamine Rectal Suspension USP, EnemaprescriptionHuman PrescriptionPerrigo New York Inc2012-03-082458020098
4a666d21d-da21-498d-aea2-055326cafd70 (view SPL)sfROWASA (mesalamine) Rectal Suspension 4g/60ml Sulfite-Free FormulationprescriptionHuman PrescriptionAlaven PharmaceuticalANALYSIS, MANUFACTURE2009-10-202682200022
5d50f2c37-5675-49f3-bdd4-3b16d333ed40 (view SPL)Mesalamine Rectal Suspension USP, EnemaprescriptionHuman PrescriptionPerrigo New York Inc2010-12-133458020923
6dfeede98-5520-4fd1-be02-4971453f9e24 (view SPL)Rectal Suspension Enema 4 grams/unit (60 mL)prescriptionHuman PrescriptionGavis Pharmaceuticals, LlcMANUFACTURE2009-12-171433860510
7eb5bcaab-0f86-4817-9373-0a5e5e1982d2 (view SPL)Mesalamine Rectal Suspension USP, EnemaprescriptionHuman PrescriptionPerrigo New York Inc2010-02-172458020923

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