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FDA Drug Application 103705 by GENENTECH

Application Number103705
Application Type Biologic License Application
Sponsor ApplicantGENENTECH
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
AP011/26/1997N102660000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093345.htm 9/22/2004
AP011/26/1997N102670000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ritugen112697L.htm 9/22/2004
AP011/26/1997N102680000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ritugen112697-lab.pdf 9/22/2004
AP011/26/1997N102690000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109106.htm 9/22/2004
AP011/26/1997N240730000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM169892.pdf 11/20/2009
AP02/10/2006S136175209   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5209lbl.pdf 2/14/2006
AP02/28/2006S137635211   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5211_lbl.pdf 3/14/2006
AP02/28/2006S137645211   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5211_ltr.pdf 3/14/2006
AP09/29/2006S150275230   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf 10/2/2006
AP09/29/2006S150455230   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5230LTR.pdf 10/5/2006
AP09/29/2006S150285231   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf 10/2/2006
AP02/21/2007S159635247   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5247Ltr.pdf 3/6/2007
AP02/21/2007S160025247   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5247Lbl.pdf 3/7/2007
AP01/25/2008S189675256   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5256lbl.pdf 1/30/2008
AP01/25/2008S189835256   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5256ltr.pdf 1/30/2008
AP08/22/2007S177305259   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5259ltr.pdf 8/30/2007
AP08/22/2007S177315259   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5259lbl.pdf 8/30/2007
AP09/28/2007S181185262   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5262ltr.pdf 10/4/2007
AP09/28/2007S182315262   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5262lbl.pdf 10/10/2007
AP01/24/2008S189925263   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5263lbl.pdf 1/31/2008
AP09/8/2008S207825285   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5285ltr.pdf 9/16/2008
AP09/8/2008S207835291   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5291ltr.pdf 9/16/2008
AP010/16/2009S236695299   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103705s5299lbl.pdf 10/22/2009
AP010/16/2009S236775299   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103705s5299ltr.pdf 10/26/2009
AP02/18/2010S248195311   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf 2/19/2010
AP02/18/2010S248495311   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5311ltr.pdf 2/25/2010
AP02/18/2010S248205312   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5312lbl.pdf 2/19/2010
AP02/18/2010S248505312   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5312ltr.pdf 2/25/2010
AP01/28/2011S276335332   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5332lbl.pdf 1/31/2011
AP01/28/2011S277195332   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5332ltr.pdf 2/4/2011
AP01/6/2011S275005343   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5343lbl.pdf 1/10/2011
AP01/6/2011S275355343   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5343ltr.pdf 1/14/2011
AP04/19/2011S285955344   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5344lbl.pdf 4/21/2011
AP04/19/2011S286025344   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5344ltr.pdf 4/22/2011
AP04/19/2011S400985344   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/103705Orig1s5344.pdf 8/1/2014
AP02/17/2012S318485362   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5362lbl.pdf 2/22/2012
AP02/17/2012S318705362   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705s5362ltr.pdf 2/23/2012
AP010/19/2012SE2341265367   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf 10/19/2012
AP010/19/2012SE2341385367   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388ltr.pdf 10/22/2012
AP04/13/2012SLR324755370   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5370ltr.pdf 4/19/2012
AP04/13/2012SLR325135370   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5370mg.pdf 4/24/2012
AP04/13/2012SLR325145370   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5370lbl.pdf 4/24/2012
AP07/13/2012SLR332065373   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5373ltr.pdf 7/17/2012
AP07/13/2012SLR333165373   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5373lbl.pdf 7/30/2012
AP010/19/2012SLR341275388   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf 10/19/2012
AP010/19/2012SLR341395388   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388ltr.pdf 10/22/2012
AP05/9/2013SLR360365409   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5409ltr.pdf 5/13/2013
AP05/9/2013SLR360545409   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5409lbl.pdf 5/14/2013
AP09/24/2013SLR372255414   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5414ltr.pdf 9/26/2013
AP09/24/2013SLR372525414   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5414lbl.pdf 9/27/2013
AP08/12/2014SLR402225432   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103705s5432lbl.pdf 8/13/2014
AP08/12/2014SLR402335432   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103705Orig1s5432ltr.pdf 8/14/2014




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