adalimumab Injection

Brand(s)
Humira
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abbvie Inc. (2015-09-09)
Oldest Current Product
2002-12-30
License(s)
BLA
RxNORM
INJECTION\ADALIMUMAB
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\ADALIMUMAB
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\ADALIMUMAB

product(s) by strength(s)

0.8 ml adalimumab 50 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743797HumiraBLAAbbvie Inc.2002-12-30ADALIMUMABSUBCUTANEOUSINJECTION, SOLUTION125057608d4f0d-b19f-46d3-749a-7159aa5f933d

application(s)

#idtitleapprovedtradenamesfda division
1125057adalimumab Application2002-12-31HumiraCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1608d4f0d-b19f-46d3-749a-7159aa5f933d (view SPL)These highlights do not include all the information needed to use HUMIRA safely and effectively. See full prescribing information for HUMIRA.HUMIRA (adalimumab) injection, for subcutaneous useInitial U.S. Approval: 2002prescriptionHuman PrescriptionAbbvie Inc.2015-09-091805000743797, 000743799, 000744339, 000746347, 000749374

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