FDA.reportPublic FDA data

AMJEVITA 80 MG in 0.8 ML Prefilled Syringe

RxCUI
2663913
RxNorm name
AMJEVITA 80 MG in 0.8 ML Prefilled Syringe
Display name
AMJEVITA 80 MG in 0.8 ML Prefilled Syringe
Full name
AMJEVITA 80 MG in 0.8 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761024Amjevitaadalimumab-atto351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9c44bd5b-4464-40a4-8933-8680950f00f2AMJEVITA 80 MG in 0.8 ML Prefilled SyringePSN35These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA ® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product known as a reference product, and that there are no clinically meaningful differences b20260310
9c44bd5b-4464-40a4-8933-8680950f00f2Amjevita 80 MG per 0.8 ML Prefilled SyringeSY35These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA ® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product known as a reference product, and that there are no clinically meaningful differences b20260310
9c44bd5b-4464-40a4-8933-8680950f00f20.8 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]SBD35These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA ® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product known as a reference product, and that there are no clinically meaningful differences b20260310