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FDA Drug Application 125075 by GENENTECH

Application Number125075
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
AP010/27/2003N6907000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/125075-0ltr.pdf 11/18/2003
AP010/27/2003N10455000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/125075_0000_RaptivaTOC.cfm 10/25/2004
AP010/27/2003N24060000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM153098.pdf 11/20/2009
AP010/27/2003N32466000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm133337.htm 4/18/2012
AP06/10/2005S118220031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125075_0031ltr.pdf 6/16/2005
AP06/10/2005S118230031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125075_0031_lbl.pdf 6/16/2005
AP010/16/2008S21063096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125075s096,s102ltr.pdf 10/23/2008
AP010/16/2008S21062102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125075s096,s102ltr.pdf 10/23/2008
AP03/13/2009S22001130   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125075s130ltr.pdf 3/16/2009
AP03/13/2009S22002130   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125075s130lbl.pdf 3/16/2009




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