abatacept Injection

Brand(s)
Orencia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-06-30)
Oldest Current Product
2009-01-01
License(s)
BLA
RxNORM
INJECTION\ABATACEPT
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ABATACEPT
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ABATACEPT

product(s) by strength(s)

abatacept 250 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000032187OrenciaBLAE.R. Squibb & Sons, L.L.C.2009-01-01ABATACEPTINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1251180836c6ac-ee37-5640-2fed-a3185a0b16eb

application(s)

#idtitleapprovedtradenamesfda division
1125118abatacept Application2005-12-23OrenciaCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
10836c6ac-ee37-5640-2fed-a3185a0b16eb (view SPL)These highlights do not include all the information needed to use ORENCIA safely and effectively. See full prescribing information for ORENCIA. ORENCIA (abatacept)for injection for intravenous useinjection, for subcutaneous useInitial U.S. Approval: 2005prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-06-3015000032187, 000032188abatacept Prefilled Syringe

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