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FDA Drug Application 103951 by AMGEN

Application Number103951
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
AP09/17/2001N75730000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080442.htm 1/21/2004
AP09/17/2001N75740000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/darbamg091701L.htm 1/21/2004
AP09/17/2001N75750000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/darbamg091701LB.htm 1/21/2004
AP09/17/2001N247410000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085918.pdf 2/5/2010
AP09/17/2001N247790000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=6 2/16/2010
AP07/19/2002S78855001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/darbamg071902L.htm 3/11/2004
AP07/19/2002S78865001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB.pdf 3/11/2004
AP07/19/2002S102715001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB2.pdf 9/22/2004
AP07/19/2002S308575001   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2002/103951Orig1s5001.pdf 12/2/2011
AP012/16/2004S110205069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103951_5069ltr.pdf 1/26/2005
AP012/16/2004S110355069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103951_5069lbl.pdf 1/26/2005
AP012/15/2005S135975088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5088lbl.pdf 2/8/2006
AP012/15/2005S136165088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5088ltr.pdf 2/8/2006
AP010/26/2005S132935096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103951s5096ltr.pdf 12/16/2005
AP010/26/2005S132975096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103951s5096lbl.pdf 12/16/2005
AP03/23/2006S138685097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5097ltr.pdf 4/5/2006
AP03/23/2006S138695097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5097LBL.pdf 4/5/2006
AP05/5/2008S       
AP04/10/2007S162475135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5135ltr .pdf 4/20/2007
AP04/10/2007S162815135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5135LBL.pdf 4/20/2007
AP03/9/2007S160055139   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5139lbl.pdf 3/9/2007
AP03/9/2007S160255139   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5139ltr.pdf 3/15/2007
AP011/8/2007S183455164   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5164ltr.pdf 11/8/2007
AP011/8/2007S183465164   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164lbl.pdf 11/8/2007
AP011/8/2007S183505164   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164ppi.pdf 11/8/2007
AP012/17/2007S189665169   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5169lbl.pdf 1/30/2008
AP012/17/2007S189905169   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5169ltr.pdf 1/31/2008
AP03/7/2008S194175170   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170lbl.pdf 3/11/2008
AP03/7/2008S194225170   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170ppi.pdf 3/12/2008
AP03/7/2008S194345170   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5170ltr.pdf 3/13/2008
AP06/24/2011S292425173   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf 6/24/2011
AP06/24/2011S292445173   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf 6/24/2011
AP06/24/2011S327645173   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173SumR.pdf 5/25/2012
AP06/24/2011S331975173   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103951_aranesp_toc.cfm 7/16/2012
AP011/19/2008S212925195   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5195PI.pdf 11/26/2008
AP011/19/2008S286205195   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5195ltr.pdf 4/28/2011
AP02/16/2010S247735197   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103951s5197ltr.pdf 2/16/2010
AP02/16/2010S247745197   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197lbl.pdf 2/16/2010
AP010/13/2009S247205211   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103951s5211Lbl.pdf 2/4/2010
AP010/13/2009S247325211   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103951s5211ltr.pdf 2/5/2010
AP01/11/2010S247195223   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5223LBL.pdf 2/4/2010
AP06/24/2011S292485248   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951s5248,103234s5256ltr.pdf 6/24/2011
AP06/24/2011S292435258   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf 6/24/2011
AP06/24/2011S292455258   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf 6/24/2011
AP05/31/2012S327935285   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103951s5285ltr.pdf 6/4/2012
AP05/31/2012S328195285   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103951s5285lbl.pdf 6/6/2012
AP012/31/2013SLR382085325   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5325ltr.pdf 1/2/2014
AP012/31/2013SLR382215325   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5325lbl.pdf 1/7/2014
AP03/27/2013SLR355635337   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5337ltr.pdf 3/29/2013
AP012/31/2013SLR382095349   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5349ltr.pdf 1/2/2014
AP012/31/2013SLR382235349   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5349lbl.pdf 1/7/2014
AP04/17/2014SLR390995353   http://deleted per r. berger 4/18/2014
AP07/23/2015SE8434725363   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103951Orig1s5363ltr.pdf 7/24/2015
AP07/23/2015SE8434865363   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103951s5363lbl.pdf 7/24/2015
AP04/27/2016SLR457925370   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103951Orig1s5370ltr.pdf 4/28/2016




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