FDA.reportPublic FDA data

0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]

RxCUI
2627725
RxNorm name
0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]
Display name
0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]
Full name
0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]
Term type
SBD
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-4464-40a4-8933-8680950f00f20.8 ML adalimumab-atto 50 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
9c44bd5b-4464-40a4-8933-8680950f00f2Amjevita 40 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 Amjevita 50 MG/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-4464-40a4-8933-8680950f00f2AMJEVITA 40 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