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FDA Drug Application 103234 by AMGEN

Application Number103234
Application Type Biologic License Application
Sponsor ApplicantAMGEN
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
AP06/1/1989N247430000Medication Guide (Procrit)  http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088988.pdf 2/5/2010
AP06/1/1989N247440000Medication Guide (Epogen)  http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088591.pdf 2/5/2010
AP06/1/1989N247780000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=16 2/16/2010
AP012/31/1990S       
AP04/1/1993S166861015   http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/103234s1015_LBL.pdf 6/4/2007
AP06/29/1994S       
AP012/23/1996S       
AP07/26/1999S160981046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/epoamg072699L.pdf 3/23/2007
AP07/26/1999S160991046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/epoamg072699lb.pdf 3/23/2007
AP07/26/1999S161001046   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080580.htm 3/23/2007
AP010/19/2004S       
AP09/29/2000S       
AP05/21/2004S91925033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103234-5033ltr.pdf 5/21/2004
AP05/21/2004S180555033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5033.pdf 9/26/2007
AP05/7/2003S       
AP06/30/2004S97235053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103234_5053ltr.pdf 7/7/2004
AP06/30/2004S97425053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5053_Epogen_lbl.pdf 7/14/2004
AP06/30/2004S180545053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5053.pdf 9/26/2007
AP011/10/2004S180535076   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5076_AP_PKG.pdf 9/26/2007
AP011/10/2004S110155076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103234_5076ltr.pdf 1/26/2005
AP011/10/2004S110445076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5076lbl.pdf 1/26/2005
AP010/27/2005S       
AP010/26/2005S132945093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103234s5093ltr.pdf 12/16/2005
AP010/26/2005S132965093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103234s5093lbl.pdf 12/16/2005
AP010/26/2005S180525093   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103234s5093_AP_PKG.pdf 9/26/2007
AP05/11/2006S141225104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103234s5104_LTR.pdf 5/18/2006
AP05/11/2006S141315104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103234s5104_LBL.pdf 5/18/2006
AP03/9/2007S160065122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5122lbl.pdf 3/9/2007
AP03/9/2007S160265122   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5122ltr.pdf 3/15/2007
AP011/8/2007S183475158   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5158ltr.pdf 11/8/2007
AP011/8/2007S183485158   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158lbl.pdf 11/8/2007
AP011/8/2007S183495158   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158ppi.pdf 11/8/2007
AP012/17/2007S189685163   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5163lbl.pdf 1/30/2008
AP012/17/2007S189895163   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5163ltr.pdf 1/31/2008
AP03/7/2008S194185164   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164lbl.pdf 3/11/2008
AP03/7/2008S194235164   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164ppi.pdf 3/12/2008
AP06/24/2011S292415166   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103234s5166,103234s5266ltr.pdf 6/24/2011
AP06/24/2011S292465166   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf 6/24/2011
AP06/24/2011S327655166   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166SumR.pdf 5/25/2012
AP06/24/2011S331985166   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103234_epogen_procrit_toc.cfm 7/16/2012
AP011/19/2008S212795195   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5195sPI.pdf 11/25/2008
AP011/19/2008S286215195   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.pdf 4/28/2011
AP011/19/2008S286225196   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.pdf 4/28/2011
AP011/19/2008S212765196   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5196PI.pdf 11/25/2008
AP02/16/2010S247715199   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5199lbl.pdf 2/16/2010
AP02/16/2010S247725199   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103234s5199ltr.pdf 2/16/2010
AP010/13/2009S247225221   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103234s5221Lbl.pdf 2/4/2010
AP010/13/2009S247335221   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103234s5221ltr.pdf 2/5/2010
AP01/11/2010S247215232   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5232LBL.pdf 2/4/2010
AP06/24/2011S292495256   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951s5248,103234s5256ltr.pdf 6/24/2011
AP06/24/2011S292475266   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf 6/24/2011
AP06/24/2011S292405266   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103234s5166,s5266ltr.pdf 6/24/2011
AP05/31/2012S328205281   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103234s5281lbl.pdf 6/6/2012
AP05/31/2012S328375281   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103234s5281ltr.pdf 6/7/2012
AP012/31/2013SLR382105323   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103234Orig1s5323ltr.pdf 1/2/2014
AP012/31/2013SLR382225323   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103234s5323lbl.pdf 1/7/2014
AP03/27/2013SLR355645329   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103234Orig1s5329ltr.pdf 3/29/2013




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