belimumab Injection

Brand(s)
Benlysta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Human Genome Sciences, Inc. (2015-07-23)
Oldest Current Product
2011-03-10
License(s)
BLA
RxNORM
INJECTION\BELIMUMAB
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BELIMUMAB
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BELIMUMAB

product(s) by strength(s)

belimumab 120 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1494010101BenlystaBLAHuman Genome Sciences, Inc.2011-03-10BELIMUMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1253702fa3c528-1777-4628-8a55-a69dae2381a3

belimumab 400 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1494010102BenlystaBLAHuman Genome Sciences, Inc.2011-03-10BELIMUMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1253702fa3c528-1777-4628-8a55-a69dae2381a3

application(s)

#idtitleapprovedtradenamesfda division
1125370belimumab Application2011-03-09BenlystaCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12fa3c528-1777-4628-8a55-a69dae2381a3 (view SPL)These highlights do not include all the information needed to use BENLYSTA safely and effectively. See full prescribing information for BENLYSTA.BENLYSTA (belimumab)for injection, for intravenous use onlyInitial U.S. Approval: 2011prescriptionHuman PrescriptionHuman Genome Sciences, Inc.2015-07-2312494010101, 494010102

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