sevelamer Oral Tablet

Brand(s)
RenaGel, Renvela
Category(s)
prescription
SPL Type(s)
Human Prescription, Human Prescription with Highlights
Master SPL
Genzyme Corporation (2015-11-11)
Oldest Current Product
2008-06-06
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
ORAL TABLET\SEVELAMER
FDAOB
ORAL\TABLET\SEVELAMER CARBONATE
ORAL\TABLET\SEVELAMER HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\SEVELAMER CARBONATE
ORAL\TABLET\SEVELAMER HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\SEVELAMER
ORAL\TABLET\SEVELAMER

product(s) by strength(s)

sevelamer carbonate 800 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680130RenvelaNDAGenzyme Corporation2009-08-12SEVELAMER CARBONATEORALTABLET, FILM COATEDNDA022127e6328460-a57b-450b-a48c-6dcd4b476360

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151494NDA AUTHORIZED GENERICGlobal Pharmaceuticals2014-04-16SEVELAMER CARBONATEORALTABLET, FILM COATEDNDA0221275fda5030-f763-46af-93be-72edd2c7df14

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790043RenvelaNDAKaiser Foundations Hospitals2010-02-12SEVELAMER CARBONATEORALTABLET, FILM COATED584680130NDA0221276178c669-a2e5-4a82-9ca2-7dfef56b63b9
2551549728RenvelaNDACardinal Health2009-08-12SEVELAMER CARBONATEORALTABLET, FILM COATED584680130NDA022127970da28b-04e4-4ec8-9d7b-1b74a0ec411d
3681515113RenvelaNDACarilion Materials Management2009-08-12SEVELAMER CARBONATEORALTABLET, FILM COATED584680130NDA02212756ccbfc1-4763-46cd-b71c-d6753a4ad23e

sevelamer hydrochloride 400 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680020NDAGenzyme Corporation2008-06-06SEVELAMER HYDROCHLORIDEORALTABLETNDA0211795e30120b-f2bf-43a0-86b2-44ae996dc681

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551549726RenaGelNDACardinal Health2008-06-06SEVELAMER HYDROCHLORIDEORALTABLET584680020NDA021179aa991f60-7c13-49ec-862b-47cca4db3c44

sevelamer hydrochloride 800 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680021NDAGenzyme Corporation2008-06-06SEVELAMER HYDROCHLORIDEORALTABLETNDA0211795e30120b-f2bf-43a0-86b2-44ae996dc681

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560021RenaGelNDAAtlantic Biologicals Corps2008-06-06SEVELAMER HYDROCHLORIDEORALTABLET584680021NDA021179ee835dc1-36b7-4447-a5c6-5ed9e06a839d
2521250435NDARemedyrepack Inc.2013-05-15SEVELAMER HYDROCHLORIDEORALTABLET584680021NDA021179b2a373e4-110e-4f9a-9abe-e0c4374770d4
3538080777NDAState Of Florida Doh Central Pharmacy2009-07-01SEVELAMER HYDROCHLORIDEORALTABLET584680021NDA0211794a3b3dd8-9b4a-4a00-8178-eb8417195081
4551549727RenaGelNDACardinal Health2008-06-06SEVELAMER HYDROCHLORIDEORALTABLET584680021NDA021179aa991f60-7c13-49ec-862b-47cca4db3c44
5675440656NDAAphena Pharma Solutions - Tennessee, Inc.2008-06-06SEVELAMER HYDROCHLORIDEORALTABLET584680021NDA021179b27c1744-1d96-4f9f-b621-e24a795b7534

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021179RENAGELGENZYME CORP2000-07-12p6733780, SUBSTANCE
p5667775, PHOSPHATE BINDING
NDA021179_001, NDA021179_002
2NDA022127RENVELAGENZYME CORP2007-10-19p7985418, SUBSTANCE
p5667775, PHOSPHATE BINDING
NDA022127_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021179_001RXSEVELAMER HYDROCHLORIDE (400MG)ORALTABLETFalse2000-07-12RENAGEL
2NDA021179_002RXSEVELAMER HYDROCHLORIDE (800MG)ORALTABLETTrue2000-07-12RENAGEL
3NDA022127_001RXSEVELAMER CARBONATE (800MG)ORALTABLETTrue2007-10-19RENVELA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5667775 (view patent)2014-09-16NDA021179, NDA022127, NDA020926, NDA022318sevelamer Oral Suspension
2p6733780 (view patent)2020-10-18NDA021179
3p7985418 (view patent)2025-10-27NDA022127

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
14a3b3dd8-9b4a-4a00-8178-eb8417195081 (view SPL)These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000prescriptionHuman Prescription with HighlightsState Of Florida Doh Central Pharmacyrepack2010-06-011538080777
256ccbfc1-4763-46cd-b71c-d6753a4ad23e (view SPL)These highlights do not include all the information needed to use Renvela safely and effectively. See full prescribing information for Renvela. Renvela (sevelamer carbonate) Tablet, Film Coated for Oral use Renvela (sevelamer carbonate) For Oral Suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-12-062681515113
35e30120b-f2bf-43a0-86b2-44ae996dc681 (view SPL)These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionGenzyme CorporationANALYSIS, API MANUFACTURE, MANUFACTURE2015-08-0613584680020, 584680021
45fda5030-f763-46af-93be-72edd2c7df14 (view SPL)These highlights do not include all the information needed to use sevelamer carbonate safely and effectively. See full prescribing information for sevelamer carbonate. Sevelamer Carbonate Tablet, Film Coated for Oral useSevelamer Carbonate For Oral SuspensionInitial U.S. Approval: 2000prescriptionHuman PrescriptionGlobal PharmaceuticalsANALYSIS, MANUFACTURE2014-01-171001151494
56178c669-a2e5-4a82-9ca2-7dfef56b63b9 (view SPL)These highlights do not include all the information needed to use Renvela safely and effectively. See full prescribing information for Renvela. Renvela (sevelamer carbonate) Tablet, Film Coated for Oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2011-08-315001790043
6970da28b-04e4-4ec8-9d7b-1b74a0ec411d (view SPL)These highlights do not include all the information needed to use Renvela safely and effectively. See full prescribing information for Renvela. Renvela (sevelamer carbonate) Tablet, Film Coated for Oral use Renvela (sevelamer carbonate) For Oral Suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2013-11-053551549728
7aa991f60-7c13-49ec-862b-47cca4db3c44 (view SPL)These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2015-10-195551549726, 551549727
8b27c1744-1d96-4f9f-b621-e24a795b7534 (view SPL)These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-04-221675440656
9b2a373e4-110e-4f9a-9abe-e0c4374770d4 (view SPL)These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-151521250435
10e6328460-a57b-450b-a48c-6dcd4b476360 (view SPL)These highlights do not include all the information needed to use Renvela safely and effectively. See full prescribing information for Renvela. Renvela (sevelamer carbonate) Tablet, Film Coated for Oral use Renvela (sevelamer carbonate) For Oral Suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionGenzyme CorporationANALYSIS, API MANUFACTURE, MANUFACTURE2015-11-1113584680130, 584680131, 584680132sevelamer Oral Suspension
11ee835dc1-36b7-4447-a5c6-5ed9e06a839d (view SPL)These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2012-12-063178560021

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