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FDA Drug Application 103964 by HOFFMAN-LA ROCHE

Application Number103964
Application Type Biologic License Application
Sponsor ApplicantHOFFMAN-LA ROCHE
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
AP010/16/2002N80590000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof101602L.htm 3/25/2004
AP010/16/2002N80600000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm 3/25/2004
AP010/16/2002N80610000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080721.htm 3/25/2004
AP010/16/2002N158410000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088679.pdf 2/20/2007
AP012/3/2002S80625000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof120302L.htm 3/25/2004
AP012/3/2002S80635000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof120302LB.htm 3/25/2004
AP012/21/2004S110215036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103964_5036ltr.pdf 1/26/2005
AP012/21/2004S110385036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103964_5036lbl.pdf 1/26/2005
AP05/13/2005S116795037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5037ltr.pdf 5/20/2005
AP05/13/2005S116825037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964s5037lbl.pdf 5/20/2005
AP02/25/2005S112095039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964_5039lbl.pdf 2/25/2005
AP02/25/2005S112105039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964_5039ltr.pdf 3/3/2005
AP05/13/2005S116805057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5057ltr.pdf 5/20/2005
AP05/13/2005S116815065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5065ltr.pdf 5/20/2005
AP06/19/2007S169125120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103964s5120ltr.pdf 7/5/2007
AP06/19/2007S169545120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103964s5120lbl.pdf 7/5/2007
AP010/31/2008S212035133   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5133ltr.pdf 11/7/2008
AP010/31/2008S216565133   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5133lbl.pdf 1/16/2009
AP04/20/2009S224675147   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf 5/7/2009
AP04/20/2009S224755147   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf 5/8/2009
AP09/18/2008S216545154   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5154lbl.pdf 1/16/2009
AP09/18/2008S209135154   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5154ltr.pdf 10/2/2008
AP04/20/2009S224765163   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf 5/8/2009
AP04/20/2009S224685163   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf 5/7/2009
AP05/24/2010S258585176   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5176ltr.pdf 6/29/2010
AP03/3/2010S251495177   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5177ltr.pdf 3/31/2010
AP02/23/2011S280205183   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5183ltr.pdf 3/2/2011
AP02/23/2011S280395183   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5183lbl.pdf 3/4/2011
AP05/27/2011S290125184   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5184lbl.pdf 5/31/2011
AP08/9/2011S297345186   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf 8/11/2011
AP08/9/2011S297405186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5186lbl.pdf 8/11/2011
AP09/29/2011S302105204   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf 10/4/2011
AP09/29/2011S302235204   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5204ltr.pdf 10/5/2011
AP08/22/2011S298675213   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf 8/24/2011
AP08/22/2011S298865213   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf 8/26/2011
AP05/16/2013SLR360945241   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5241ltr.pdf 5/21/2013
AP05/16/2013SLR360995241   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5241lbl.pdf 5/21/2013
AP07/2/2013SLR364365245   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5245ltr.pdf 7/3/2013
AP07/2/2013SLR364425245   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5245lbl.pdf 7/3/2013
AP09/5/2014SLR404475261   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103964Orig1s5261ltr.pdf 9/8/2014
AP09/5/2014SLR404605261   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103964s5261lbl.pdf 9/9/2014
AP03/18/2015SLR422065264   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103964s5264lbl.pdf 3/19/2015
AP03/18/2015SLR422165264   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103964Orig1s5264ltr.pdf 3/19/2015




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