abatacept Prefilled Syringe

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
2011-07-29
License(s)
BLA
RxNORM
PREFILLED SYRINGE\ABATACEPT
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\ABATACEPT
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\ABATACEPT

product(s) by strength(s)

1 ml abatacept 125 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000032188OrenciaBLAE.R. Squibb & Sons, L.L.C.2011-07-29ABATACEPTSUBCUTANEOUSINJECTION, 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.2015-06-3015000032188, 000032187abatacept Injection

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