lanthanum carbonate Oral Powder

Brand(s)
Fosrenol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shire (2014-09-24)
Oldest Current Product
2014-09-24
License(s)
NDA
RxNORM
ORAL POWDER\LANTHANUM CARBONATE
FDAOB
ORAL\POWDER\LANTHANUM CARBONATE
SPL Active
ORAL\POWDER\LANTHANUM CARBONATE
SPL Moiety
ORAL\POWDER\LANTHANUM CATION (3+)

product(s) by strength(s)

lanthanum carbonate 1000 mg oral powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1540920257FosrenolNDAShire2014-09-24LANTHANUM CARBONATEORALPOWDERNDA204734f10776b2-2c25-4343-aabe-68f302e5cb54

lanthanum carbonate 750 mg oral powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1540920256FosrenolNDAShire2014-09-24LANTHANUM CARBONATEORALPOWDERNDA204734f10776b2-2c25-4343-aabe-68f302e5cb54

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA204734FOSRENOLSHIRE DEVELOPMENT LLC2014-09-24p8980327, SUBSTANCE
p5968976, TO REDUCE SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE, SUBSTANCE
p7465465, SUBSTANCE
NDA204734_001, NDA204734_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204734_001RXLANTHANUM CARBONATE (EQ 750MG BASE)ORALPOWDERFalse2014-09-24FOSRENOL
2NDA204734_002RXLANTHANUM CARBONATE (EQ 1GM BASE)ORALPOWDERTrue2014-09-24FOSRENOL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5968976 (view patent)2018-10-26NDA204734, NDA021468lanthanum carbonate Chewable Tablet
2p7465465 (view patent)2024-08-26NDA204734, NDA021468lanthanum carbonate Chewable Tablet
3p8980327 (view patent)2030-12-01NDA204734

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1f10776b2-2c25-4343-aabe-68f302e5cb54 (view SPL)These highlights do not include all the information needed to use FOSRENOL safely and effectively. See full prescribing information for FOSRENOL. FOSRENOL (lanthanum carbonate) chewable tablets, for oral use FOSRENOL (lanthanum carbonate) oral powder, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionShireANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-09-2439540920256, 540920257, 540920252, 540920253, 540920254lanthanum carbonate Chewable Tablet

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