Humira

BLA 125057, held by Abbvie Inc. Adalimumab.

First approved: Dec 31, 2002
Review: Standard
Supplements approved: 60
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 61 submissions below

Date	Submission	Status	Documents
Feb 24, 2021	Supplement 417Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 16, 2020	Supplement 419Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 16, 2018	Supplement 409Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 28, 2018	Supplement 408Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 2, 2018	Supplement 406Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 27, 2017	Supplement 399Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 30, 2016	Supplement 397Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 23, 2015	Supplement 394Efficacy (new indication or use) · Standard review	Approved	Summary Review Label Letter
Sep 9, 2015	Supplement 393Efficacy (new indication or use) · Standard review	Approved	Review Letter
Sep 30, 2014	Supplement 367Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 23, 2014	Supplement 356Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 28, 2012	Supplement 232Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 25, 2011	Supplement 215Efficacy (new indication or use) · Standard review	Approved	Label
Feb 21, 2008	Supplement 114Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jan 18, 2008	Supplement 110Efficacy (new indication or use) · Standard review	Approved	Summary Review Review Label Letter
Jul 30, 2007	Supplement 94Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 27, 2007	Supplement 89Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Feb 16, 2007	Supplement 60Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2006	Supplement 71Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2006	Supplement 95Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 28, 2006	Supplement 62Efficacy (new indication or use) · Standard review	Approved	Label
Oct 3, 2005	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 3, 2005	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jul 30, 2004	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 31, 2002	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review Pediatric Medical Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Humira40MG/0.8ML · syringe	Adalimumab	Rx
Humira40MG/0.8ML · vial	Adalimumab	Rx

All 61 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 23, 2025	Supplement 425Labeling · Standard review	Approved	Label Letter
Jul 16, 2025	Supplement 424Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 3, 2023	Supplement 423Labeling · Standard review	Approved	Letter Label
Feb 24, 2021	Supplement 417Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 16, 2020	Supplement 418Labeling · Standard review	Approved	Letter Label
Dec 16, 2020	Supplement 419Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 11, 2020	Supplement 415Labeling · Standard review	Approved	Letter Label
Jan 11, 2019	Supplement 411Labeling · Standard review	Approved	Label Letter
Dec 6, 2018	Supplement 410Labeling · Standard review	Approved	Label Letter
Oct 16, 2018	Supplement 409Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 28, 2018	Supplement 408Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 2, 2018	Supplement 406Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 14, 2017	Supplement 403Labeling · Standard review	Approved	Label Letter
Apr 28, 2017	Supplement 402Manufacturing · Standard review	Approved	Letter Label
Apr 21, 2017	Supplement 401Manufacturing · Standard review	Approved	Label
Mar 27, 2017	Supplement 399Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 17, 2016	Supplement 400Manufacturing	Approved	Label
Jun 30, 2016	Supplement 397Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 23, 2015	Supplement 394Efficacy (new indication or use) · Standard review	Approved	Summary Review Label Letter
Sep 9, 2015	Supplement 393Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 24, 2014	Supplement 280Manufacturing	Approved	Letter
Nov 6, 2014	Supplement 390Labeling · Standard review	Approved	None posted
Oct 29, 2014	Supplement 384Labeling · Standard review	Approved	None posted
Sep 30, 2014	Supplement 367Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 23, 2014	Supplement 356Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Aug 7, 2014	Supplement 381Manufacturing	Approved	Review
May 30, 2014	Supplement 366Labeling · Standard review	Approved	Label Letter
May 14, 2014	Supplement 368Labeling · Standard review	Approved	Letter Label
Feb 26, 2014	Supplement 355Labeling · Standard review	Approved	Letter Label
Sep 19, 2013	Supplement 327Labeling · Standard review	Approved	Label Letter
May 13, 2013	Supplement 310Labeling · Standard review	Approved	Letter Label
Apr 24, 2013	Supplement 322Labeling · Standard review	Approved	Review Label
Sep 28, 2012	Supplement 232Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
May 24, 2012	Supplement 278Labeling · Standard review	Approved	Letter Label
Dec 26, 2011	Supplement 276Labeling · Standard review	Approved	Label Letter
Dec 13, 2011	Supplement 271Labeling · Standard review	Approved	Letter
Sep 7, 2011	Supplement 255Labeling · Standard review	Approved	Letter
Jul 13, 2011	Supplement 254Labeling · Standard review	Approved	Letter
Mar 14, 2011	Supplement 128Labeling · Standard review	Approved	Letter
Feb 25, 2011	Supplement 215Efficacy (new indication or use) · Standard review	Approved	Label
Nov 18, 2010	Supplement 196Labeling · Standard review	Approved	Label Letter
Sep 29, 2010	Supplement 224Labeling · Standard review	Approved	Letter
Jul 29, 2010	Supplement 213Labeling · Standard review	Approved	Review Letter
Apr 8, 2010	Supplement 161Labeling · Standard review	Approved	Letter
Mar 11, 2009	Supplement 141Labeling · Standard review	Approved	None posted
Feb 21, 2008	Supplement 114Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jan 18, 2008	Supplement 110Efficacy (new indication or use) · Standard review	Approved	Summary Review Review Label Letter
Sep 5, 2007	Supplement 108Labeling · Standard review	Approved	Letter Label
Jul 30, 2007	Supplement 94Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 27, 2007	Supplement 89Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Feb 16, 2007	Supplement 60Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2006	Supplement 71Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2006	Supplement 95Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 28, 2006	Supplement 62Efficacy (new indication or use) · Standard review	Approved	Label
Jun 23, 2006	Supplement 65Labeling · Standard review	Approved	None posted
Oct 3, 2005	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 3, 2005	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jul 30, 2004	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 18, 2004	Supplement 23	Approved	Review Letter
Sep 12, 2003	Supplement 4Labeling · Standard review	Approved	None posted
Dec 31, 2002	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review Pediatric Medical Review

Show all 61

Identifiers

Application: BLA 125057
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters