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FDA Drug Application 125147 by AMGEN

Application Number125147
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
AP09/27/2006N150220000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125147s0000lbl.pdf 9/28/2006
AP09/27/2006N150390000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125147LTR.pdf 10/2/2006
AP09/27/2006N154040000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125147s0000TOC.cfm 11/30/2006
AP011/6/2007S185730018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125147s018ltr.pdf 11/19/2007
AP011/6/2007S186040018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125147s018lbl.pdf 12/3/2007
AP05/5/2009S224590067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s067lbl.pdf 5/7/2009
AP05/5/2009S224690067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125147s0067ltr.pdf 5/8/2009
AP07/17/2009S230030080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s080lbl.pdf 7/21/2009
AP08/17/2012S335230148   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125147s0148lbl.pdf 8/20/2012
AP08/17/2012S335320148   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s0148ltr.pdf 8/21/2012
AP06/23/2008S20162026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125147s026ltr.pdf 7/8/2008
AP06/23/2008S20194026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125147s026lbl.pdf 7/14/2008
AP05/23/2014SE839375108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s108lbl.pdf 5/28/2014
AP05/23/2014SE839350108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s108ltr.pdf 5/27/2014
AP08/17/2012S33552152   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s152ltr.pdf 8/27/2012
AP03/28/2013SLR35579169   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125147Orig1s169ltr.pdf 4/1/2013
AP03/28/2013SLR35613169   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125147s169lbl.pdf 4/1/2013
AP05/23/2014SE839349186   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s186ltr.pdf 5/27/2014
AP05/23/2014SE839374186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s186lbl.pdf 5/28/2014
AP08/30/2014SLR40374194   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s194ltr.pdf 9/3/2014
AP08/30/2014SLR40392194   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s194lbl.pdf 9/3/2014
AP03/11/2015SLR42111200   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125147Orig1s200ltr.pdf 3/12/2015
AP03/11/2015SLR42120200   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125147s200lbl.pdf 3/12/2015




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