HUMIRA (adalimumab) BLA 125057

by ABBOTT

attributevalue
Drug NameHUMIRA
Application Number125057
Active Ingredient(s)ADALIMUMAB
CompanyABBOTT
Dosages/Routes/Forms
Drug NameActive Ingredient(s)StrengthForm/RouteMarketing StatusRLDTE Code
HUMIRAADALIMUMAB40MG/0.8MLSYRINGE10
HUMIRAADALIMUMAB40MG/0.8MLVIAL10
Approval History
DateSupplement No.ActionDocuments
May 13, 2013310Labeling Revision
Apr 24, 2013322Manufacturing Change or Addition
Feb 27, 20070089Supplement
Sep 28, 2012232New or Modified Indication
May 24, 20120278Supplement
Dec 26, 2011276Supplement
Jul 13, 2011254Supplement
Dec 13, 2011271Supplement
Dec 31, 20020000Approval
Sep 07, 2011255Supplement
Mar 14, 2011128Supplement
Feb 25, 20110215Supplement
Sep 29, 2010224Supplement
Jul 29, 20100213Supplement
Apr 08, 2010161Supplement
Nov 18, 20090196Supplement
Jan 18, 20080110Supplement
Feb 21, 20080114Supplement
Sep 05, 20070108Supplement
Jul 30, 20070094Supplement
Feb 16, 20070060Supplement
Nov 09, 20060095Supplement
Nov 09, 20060071Supplement
Aug 28, 20060062Supplement
Oct 03, 20050045Supplement
Oct 03, 20050046Supplement
Jul 30, 20040016Supplement
Jun 18, 20040023Supplement