FDA.reportPublic FDA data

adalimumab-bwwd 40 MG in 0.8 ML Auto-Injector

RxCUI
2640287
RxNorm name
adalimumab-bwwd 40 MG in 0.8 ML Auto-Injector
Display name
adalimumab-bwwd 40 MG in 0.8 ML Auto-Injector
Full name
adalimumab-bwwd 40 MG in 0.8 ML Auto-Injector
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761059Hadlimaadalimumab-bwwd351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4774a951-3ce8-43b6-80b1-e6b23752aae6adalimumab-bwwd 40 MG in 0.8 ML Auto-InjectorPSN13These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) 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 betwee20251017
4774a951-3ce8-43b6-80b1-e6b23752aae60.8 ML adalimumab-bwwd 50 MG/ML Auto-InjectorSCD13These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) 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 betwee20251017
4774a951-3ce8-43b6-80b1-e6b23752aae6adalimumab-bwwd 40 MG per 0.8 ML Auto-InjectorSY13These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) 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 betwee20251017
ef25af7e-6267-409a-8d68-de51eb48812a0.8 ML adalimumab-bwwd 50 MG/ML Auto-InjectorSCD1These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab)20231002
ef25af7e-6267-409a-8d68-de51eb48812aadalimumab-bwwd 40 MG in 0.8 ML Auto-InjectorPSN1These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab)20231002
ef25af7e-6267-409a-8d68-de51eb48812aadalimumab-bwwd 40 MG per 0.8 ML Auto-InjectorSY1These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab)20231002