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FDA Drug Application 125268 by AMGEN

Application Number125268
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
AP08/22/2008N206610000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125268lbl.pdf 8/25/2008
AP08/22/2008N206650000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125268s000ltr.pdf 8/25/2008
AP08/22/2008N210280000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125268_romiplostim_toc.cfm 10/17/2008
AP08/22/2008N210290000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125268s000_sumR.pdf 10/17/2008
AP08/22/2008N210490000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=38 10/22/2008
AP08/14/2009S232800026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125268s0026ltr.pdf 9/9/2009
AP08/14/2009S234150026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125268s0026lbl.pdf 9/18/2009
AP03/23/2010S25722028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf 6/10/2010
AP09/18/2009S       
AP03/23/2010S25723036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf 6/10/2010
AP012/6/2011S30884077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125268s077lbl.pdf 12/6/2011
AP012/6/2011S30956077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125268s077ltr.pdf 12/14/2011
AP011/2/2012SLR34294106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125268s106lbl.pdf 11/6/2012
AP011/2/2012SLR34295106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125268s106mg.pdf 11/6/2012
AP011/2/2012SLR34324106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125268Orig1s106ltr.pdf 11/7/2012
AP05/30/2013SLR36171121   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125268Orig1s121ltr.pdf 5/31/2013
AP05/30/2013SLR36212121   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125268s121lbl.pdf 6/4/2013
AP02/10/2014SLR38500141   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125268s141lbl.pdf 2/11/2014
AP02/10/2014SLR38505141   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125268Orig1s141ltr.pdf 2/12/2014
AP04/19/2016SLR45702155   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf 4/20/2016
AP04/19/2016SLR45710155   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156ltr.pdf 4/20/2016
AP04/19/2016SLR45703156   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf 4/20/2016
AP04/19/2016SLR45711156   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156ltr.pdf 4/20/2016
AP04/19/2016SLR47193156   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088667.pdf 9/29/2016




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