STELARA (ustekinumab) BLA 125261

by CENTOCOR ORTHO BIOTECH INC

attributevalue
Drug NameSTELARA
Application Number125261
Active Ingredient(s)USTEKINUMAB
CompanyCENTOCOR ORTHO BIOTECH INC
Dosages/Routes/Forms
Drug NameActive Ingredient(s)StrengthForm/RouteMarketing StatusRLDTE Code
STELARAUSTEKINUMAB45MG/0.5MLINJECTABLE; INJECTION10
STELARAUSTEKINUMAB90MG/1MLINJECTABLE; INJECTION10
Approval History
DateSupplement No.ActionDocuments
Apr 29, 2013099Labeling Revision
Jan 25, 2013091Labeling Revision
Jun 14, 20120059Supplement
May 31, 20120049Supplement
May 02, 20120063Supplement
Apr 06, 20120058Supplement
Oct 20, 2010013Supplement
Dec 30, 20090001Supplement
Sep 25, 2009000Approval