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FDA Drug Application 125289 by CENTOCOR ORTHO BIOTECH INC

Application Number125289
Application Type Biologic License Application
Sponsor ApplicantCENTOCOR ORTHO BIOTECH 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
AP04/24/2009N22429000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s000lbl.pdf 5/5/2009
AP04/24/2009N22430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125289s000ltr.pdf 5/6/2009
AP04/24/2009N22698000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125289s0000TOC.cfm 6/5/2009
AP04/24/2009N22699000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125289s000_SumR.pdf 6/5/2009
AP04/24/2009N24079000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152822.pdf 11/20/2009
AP04/24/2009N31042000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm 12/20/2011
AP03/22/2011S283510020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s0020ltr.pdf 3/25/2011
AP012/22/2010S274610029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s0029lbl.pdf 1/5/2011
AP012/22/2010S274660029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s0029ltr.pdf 1/6/2011
AP08/17/2011SLR313780038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0038lbl.pdf 1/11/2012
AP08/17/2011SLR314840038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s038ltr.pdf 1/24/2012
AP011/18/2009SLR24152006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125289s006ltr.pdf 11/25/2009
AP011/18/2009SLR24283006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s006lbl.pdf 12/11/2009
AP07/29/2010S26096025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s025ltr.pdf 8/3/2010
AP07/29/2010S26187025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s025lbl.pdf 8/10/2010
AP07/29/2010S26188025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s025MedGuide.pdf 8/10/2010
AP09/29/2010S26674033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s033ltr.pdf 10/19/2010
AP09/7/2011S29982053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s053ltr.pdf 9/13/2011
AP012/26/2011S31335064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s064ltr.pdf 1/3/2012
AP012/26/2011S32122064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf 3/15/2012
AP011/23/2012SLR34455070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125289Orig1s070ltr.pdf 11/26/2012
AP011/23/2012SLR34483070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125289s070lbl.pdf 11/28/2012
AP05/15/2013SE836083077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf 5/16/2013
AP05/15/2013SE836105077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf 5/21/2013
AP05/15/2013SE836106078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf 5/21/2013
AP05/15/2013SE836084078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf 5/16/2013
AP05/15/2013SE836085079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf 5/16/2013
AP05/15/2013SE836107079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf 5/21/2013
AP04/23/2013SLR35872084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s084ltr.pdf 4/30/2013
AP04/23/2013SLR35879084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s084lbl.pdf 4/30/2013
AP05/6/2013SLR35947086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s086lbl.pdf 5/6/2013
AP05/6/2013SLR35984086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s086ltr.pdf 5/8/2013
AP011/13/2013SLR37817094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s094ltr.pdf 11/14/2013
AP011/13/2013SLR37825094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s094lbl.pdf 11/15/2013
AP012/27/2013SLR38192103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s103lbl.pdf 12/30/2013
AP012/27/2013SLR38197103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s103ltr.pdf 12/31/2013
AP012/27/2013SLR40105103   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2013/125289Orig1s103.pdf 8/1/2014
AP01/24/2014SLR38366105Removed per R. Berger  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125289Orig1s105ltr.pdf 1/27/2014
AP01/24/2014SLR38388105Removed per R. Berger  http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125289s105lbl.pdf 1/28/2014
AP012/19/2014SLR41363121   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125289Orig1s121ltr.pdf 12/23/2014
AP06/16/2015SLR43070124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125289Orig1s124ltr.pdf 6/18/2015
AP06/16/2015SLR43086124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125289s024lbl.pdf 6/19/2015
AP01/8/2016SLR44951127   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125289Orig1s127ltr.pdf 1/11/2016
AP01/8/2016SLR44960127   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125289s127lbl.pdf 1/12/2016




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