← FDA DRUG APPROVALS

FDA BLA · BLA125057

HUMIRA

adalimumab

Sponsor: ABBVIE INC

APPLICATION
BLA125057
TYPE
BLA
ORIGINAL APPROVAL
2002-12-31
LATEST ACTION
2025-12-23
DOSAGE FORM
VIAL, SYRINGE
MARKETING STATUS
Prescription

Products

HUMIRAPrescription
ADALIMUMAB 40MG/0.8ML · VIAL
HUMIRAPrescription
ADALIMUMAB 40MG/0.8ML · SYRINGE

Approval history

2025-12-23Labeling · Supplement 425 · standard — Letter ↗AP
2025-07-16Labeling · Supplement 424 · standard — Letter ↗AP
2023-11-03Labeling · Supplement 423 · standard — Letter ↗AP
2021-02-24Efficacy · Supplement 417 · standard — Letter ↗AP
2020-12-16Labeling · Supplement 418 · standard — Letter ↗AP
2020-12-16Efficacy · Supplement 419 · standard — Letter ↗AP
2020-03-11Labeling · Supplement 415 · standard — Letter ↗AP
2019-01-11Labeling · Supplement 411 · standard — Letter ↗AP
2018-12-06Labeling · Supplement 410 · standard — Label ↗AP
2018-10-16Efficacy · Supplement 409 · standard — Letter ↗AP
2018-09-28Efficacy · Supplement 408 · standard — Letter ↗AP
2018-08-02Efficacy · Supplement 406 · standard — Letter ↗AP
2017-12-14Labeling · Supplement 403 · standard — Letter ↗AP
2017-04-28Manufacturing (CMC) · Supplement 402 · standard — Label ↗AP
2017-04-21Manufacturing (CMC) · Supplement 401 · standard — Label ↗AP
2017-03-27Efficacy · Supplement 399 · standard — Label ↗AP
2016-10-17Manufacturing (CMC) · Supplement 400 — Label ↗AP
2016-06-30Efficacy · Supplement 397 · standard — Label ↗AP
2015-11-23Efficacy · Supplement 394 · standard — Label ↗AP
2015-09-09Efficacy · Supplement 393 · standard — Review ↗AP
2014-12-24Manufacturing (CMC) · Supplement 280 — Letter ↗AP
2014-11-06Labeling · Supplement 390 · standardAP
2014-10-29Labeling · Supplement 384 · standardAP
2014-09-30Efficacy · Supplement 367 · standard — Label ↗AP
2014-09-23Efficacy · Supplement 356 · standard — Review ↗AP
2014-08-07Manufacturing (CMC) · Supplement 381 — Review ↗AP
2014-05-30Labeling · Supplement 366 · standard — Label ↗AP
2014-05-14Labeling · Supplement 368 · standard — Letter ↗AP
2014-02-26Labeling · Supplement 355 · standard — Label ↗AP
2013-09-19Labeling · Supplement 327 · standard — Label ↗AP
2013-05-13Labeling · Supplement 310 · standard — Letter ↗AP
2013-04-24Labeling · Supplement 322 · standard — Review ↗AP
2012-09-28Efficacy · Supplement 232 · standard — Label ↗AP
2012-05-24Labeling · Supplement 278 · standard — Letter ↗AP
2011-12-26Labeling · Supplement 276 · standard — Label ↗AP
2011-12-13Labeling · Supplement 271 · standard — Letter ↗AP
2011-09-07Labeling · Supplement 255 · standard — Letter ↗AP
2011-07-13Labeling · Supplement 254 · standard — Letter ↗AP
2011-03-14Labeling · Supplement 128 · standard — Letter ↗AP
2011-02-25Efficacy · Supplement 215 · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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