REMICADE (infliximab) BLA 103772

by CENTOCOR INC

attributevalue
Drug NameREMICADE
Application Number103772
Active Ingredient(s)INFLIXIMAB
CompanyCENTOCOR INC
Dosages/Routes/Forms
Drug NameActive Ingredient(s)StrengthForm/RouteMarketing StatusRLDTE Code
REMICADEINFLIXIMAB100MGVIAL10
Approval History
DateSupplement No.ActionDocuments
Mar 28, 20135345Labeling Revision
Jun 28, 20125328Labeling Revision
Oct 26, 20115295Supplement
Jun 12, 20075189Supplement
Sep 23, 20115301Supplement
Aug 01, 20115317Supplement
Feb 23, 20115281Supplement
Dec 29, 20105259Supplement
Nov 18, 20095258Supplement
Jul 29, 20105278Supplement
Apr 26, 20105260Supplement
Aug 24, 19980000Approval
May 05, 20095234Supplement
Dec 22, 20085232Supplement
Sep 03, 20035056Supplement
Dec 29, 20001007Supplement
Apr 19, 20075160Supplement
Sep 26, 20065129Supplement
Dec 08, 20065163Supplement
Oct 13, 20065145Supplement
Aug 11, 20065166Supplement
Aug 11, 20065167Supplement
May 19, 20065138Supplement
Sep 15, 20055113Supplement
May 18, 20055089Supplement
Apr 05, 20055092Supplement
Dec 17, 20045090Supplement
Dec 17, 20045077Supplement
Sep 29, 20045073Supplement
Jul 29, 20045058Supplement
Apr 01, 20035032Supplement
Nov 10, 19991004Supplement
Feb 27, 20025004Supplement
Jun 28, 20025012Supplement
Sep 03, 20035020Supplement