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FDA Drug Application 103772 by CENTOCOR INC

Application Number103772
Application Type Biologic License Application
Sponsor ApplicantCENTOCOR INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/24/1998N102630000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093327.htm 9/22/2004
AP08/24/1998N102640000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/inflcen082498lb.pdf 9/22/2004
AP08/24/1998N102650000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082498L.htm 9/22/2004
AP08/24/1998N141340000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm 5/19/2006
AP08/24/1998N240660000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089023.pdf 11/20/2009
AP011/10/1999S80871004   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093335.htm 3/26/2004
AP011/10/1999S80881004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/inflcen111099L.htm 3/26/2004
AP011/10/1999S80891004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen111099lb.pdf 3/26/2004
AP012/29/2000S80851007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inflcen122900L.htm 3/26/2004
AP012/29/2000S80861007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen122900LB.pdf 3/26/2004
AP012/29/2000S175151007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103772_S1007_REMICADE.pdf 8/6/2007
AP02/27/2002S80815004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen022702L.pdf 3/26/2004
AP02/27/2002S80825004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen022702LB.pdf 3/26/2004
AP06/28/2002S80835012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen062802L.pdf 3/26/2004
AP06/28/2002S80845012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen062802LB.pdf 3/26/2004
AP09/3/2003S68635020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5020ltr.pdf 11/3/2003
AP04/1/2003S80805032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/inflcen040103L.htm 3/26/2004
AP09/3/2003S68645056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5056ltr.pdf 11/3/2003
AP09/3/2003S195895056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103772_S5056_REMIICADE.pdf 4/2/2008
AP07/29/2004S99825058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5058ltr.pdf 8/10/2004
AP07/29/2004S99835058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5058lbl.pdf 8/10/2004
AP09/29/2004S103145073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073lbl.pdf 9/29/2004
AP09/29/2004S103155073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073ppi.pdf 9/29/2004
AP09/29/2004S103645073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5073ltr.pdf 10/5/2004
AP012/17/2004S108115077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5077_ltr.pdf 12/29/2004
AP012/17/2004S108335077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5077_lbl.pdf 12/29/2004
AP05/18/2005S116785089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772s5089ltr.pdf 5/20/2005
AP05/18/2005S116835089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5089lbl.pdf 5/20/2005
AP012/17/2004S111835090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5090_ltr.pdf 3/3/2005
AP04/5/2005S113905092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5092ltr.pdf 4/12/2005
AP04/5/2005S113925092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772_5092_LBL.pdf 4/12/2005
AP09/15/2005S128045113   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5113lbl.pdf 9/20/2005
AP09/15/2005S129205113   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5113ltr.pdf 10/20/2005
AP09/15/2005S449745113   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103772Orig1s5113.pdf 1/19/2016
AP09/26/2006S157855129   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5129ltr.pdf 2/12/2007
AP09/26/2006S159015129   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5129lbl.pdf 2/23/2007
AP05/19/2006S141325138   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5138ltr.pdf 5/19/2006
AP05/19/2006S141335138   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf 5/19/2006
AP010/13/2006S151595145   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5145LBL.pdf 10/23/2006
AP010/13/2006S151875145   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5145LTR.pdf 10/23/2006
AP04/19/2007S163025160   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5160_LTR.pdf 4/25/2007
AP04/19/2007S163235160   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5160_LBL.pdf 4/25/2007
AP012/8/2006S156275163   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5163ltr.pdf 1/8/2007
AP012/8/2006S156355163   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5163lbl.pdf 1/8/2007
AP08/11/2006S146905166   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf 8/14/2006
AP08/11/2006S147205166   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf 8/18/2006
AP08/11/2006S146915167   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf 8/14/2006
AP08/11/2006S147215167   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf 8/18/2006
AP06/12/2007S169225189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5189ltr.pdf 7/5/2007
AP06/12/2007S169535189   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5189lbl.pdf 7/5/2007
AP06/12/2007S317905189   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/103772Orig1s5189Approv.pdf 2/14/2012
AP012/22/2008S222895232   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103772s5232lbl.pdf 4/20/2009
AP012/22/2008S222915232   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103772s5232ltr.pdf 4/20/2009
AP05/5/2009S224605234   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5234lbl.pdf 5/7/2009
AP05/5/2009S224745234   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5234ltr.pdf 5/8/2009
AP011/18/2009S241515258   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5258ltr.pdf 11/25/2009
AP011/18/2009S263065258   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf 8/28/2010
AP012/29/2010S274625259   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5259ltr.pdf 1/6/2011
AP012/29/2010S274655259   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5259lbl.pdf 1/6/2011
AP04/26/2010S255015260   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5260lbl.pdf 5/7/2010
AP04/26/2010S255215260   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5260ltr.pdf 5/10/2010
AP07/29/2010S260945278   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5278ltr.pdf 8/3/2010
AP02/23/2011S279725281   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5281ltr.pdf 2/28/2011
AP02/23/2011S280315281   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281MedG.pdf 3/4/2011
AP02/23/2011S280325281   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf 3/4/2011
AP010/26/2011S321125295   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf 3/15/2012
AP09/23/2011S301455301   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5301ltr.pdf 9/29/2011
AP09/23/2011S301505301   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301MedG.pdf 9/30/2011
AP09/23/2011S301515301   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf 9/30/2011
AP08/1/2011S297375317   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5317ltr.pdf 8/11/2011
AP06/28/2012SLR330645328   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103772s5328ltr.pdf 6/29/2012
AP03/28/2013SLR355785345   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5345ltr.pdf 3/29/2013
AP03/28/2013SLR356115345   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf 4/1/2013
AP011/6/2013SLR377425359   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5359ltr.pdf 11/8/2013
AP011/6/2013SLR377445359   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf 11/8/2013
AP111/6/2013SLR377425359   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5359ltr.pdf 11/8/2013
AP111/6/2013SLR377445359   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf 11/8/2013
AP01/2/2015SLR414785370   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf 1/5/2015
AP01/2/2015SLR415135370   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5370ltr.pdf 1/7/2015
AP010/2/2015SLR441255373   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5373ltr.pdf 10/6/2015
AP010/2/2015SLR441785373   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5373lbl.pdf 10/8/2015
AP08/27/2015SLR437455374   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5374lbl.pdf 8/28/2015
AP08/27/2015SLR437605374   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5374ltr.pdf 9/1/2015




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