eliglustat Oral Capsule

Brand(s)
Cerdelga
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genzyme Corporation (2014-08-26)
Oldest Current Product
2014-09-03
License(s)
NDA
RxNORM
ORAL CAPSULE\ELIGLUSTAT
FDAOB
ORAL\CAPSULE\ELIGLUSTAT TARTRATE
SPL Active
ORAL\CAPSULE\ELIGLUSTAT
SPL Moiety
ORAL\CAPSULE\ELIGLUSTAT

product(s) by strength(s)

eliglustat 84 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680220CerdelgaNDAGenzyme Corporation2014-09-03ELIGLUSTATORALCAPSULENDA205494819f828a-b888-4e46-83fc-94d774a28a83

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205494CERDELGAGENZYME CORP2014-08-19p6916802, TREATMENT OF GAUCHER DISEASE TYPE 1
p7615573, TREATMENT OF GAUCHER DISEASE TYPE 1
p7196205
ORPHAN DRUG EXCLUSIVITY [2021-08-19]
NEW CHEMICAL ENTITY [2019-08-19]
NDA205494_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205494_001RXELIGLUSTAT TARTRATE (EQ 84MG BASE)ORALCAPSULETrue2014-08-19CERDELGA

patent(s)

#idexpiration dateapplication(s)
1p6916802 (view patent)2022-04-29NDA205494
2p7196205 (view patent)2022-04-29NDA205494
3p7615573 (view patent)2022-04-29NDA205494

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1819f828a-b888-4e46-83fc-94d774a28a83 (view SPL)These highlights do not include all the information needed to use CERDELGA safely and effectively. See full prescribing information for CERDELGA. CERDELGA (eliglustat) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionGenzyme CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-08-261584680220

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