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FDA Drug Application 125320 by AMGEN

Application Number125320
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
AP06/1/2010N256620000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf 6/2/2010
AP06/1/2010N256830000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214385.pdf 6/3/2010
AP06/1/2010N257030000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s0000ltr.pdf 6/4/2010
AP06/1/2010N262420000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s0000TOC.cfm 8/18/2010
AP06/1/2010N262430000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000SumR.pdf 8/18/2010
AP06/1/2010N302320000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=43 10/7/2011
AP09/16/2011S30038005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf 9/20/2011
AP09/16/2011S30040005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125320s005,s006ltr.pdf 9/20/2011
AP09/20/2012SE5338290051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320Orig1s0051ltr.pdf 9/24/2012
AP09/20/2012SE5338330051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0051mg.pdf 9/25/2012
AP09/20/2012SE5338340051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0051lbl.pdf 9/25/2012
AP05/10/2012SLR326820053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0053ltr.pdf 5/14/2012
AP05/10/2012SLR326970053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0053lbl.pdf 5/16/2012
AP04/27/2012S325710054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0054lbl.pdf 5/1/2012
AP04/27/2012S325900054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0054ltr.pdf 5/2/2012
AP09/16/2011S30039006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf 9/20/2011
AP09/16/2011S30041006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125320s005,s006ltr.pdf 9/20/2011
AP011/18/2010S26989007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf 11/19/2010
AP011/18/2010S27008007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s007ltr.pdf 11/22/2010
AP011/18/2010S44432007   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125320Orig1s007.pdf 11/9/2015
AP06/7/2012SLR328690078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0078lbl.pdf 6/11/2012
AP06/7/2012SLR328930078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0078ltr.pdf 6/11/2012
AP09/14/2012SLR337820085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320Orig1s0085ltr.pdf 9/18/2012
AP09/14/2012SLR337840085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0085lbl.pdf 9/18/2012
AP02/15/2013SLR35194080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s080lbl.pdf 2/20/2013
AP02/15/2013SLR35199080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s080ltr.pdf 2/20/2013
AP06/13/2013SE836285094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf 6/13/2013
AP06/13/2013SE836290094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s094ltr.pdf 6/13/2013
AP07/3/2013SLR36472113   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s113lbl.pdf 7/5/2013
AP07/3/2013SLR36497113   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s113ltr.pdf 7/8/2013
AP08/23/2013SLR36890114   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf 8/27/2013
AP08/23/2013SLR36904114   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s114, s124ltr.pdf 8/27/2013
AP08/23/2013SLR36891124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf 8/27/2013
AP08/23/2013SLR36905124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s114, s124ltr.pdf 8/27/2013
AP06/16/2014S39554150   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s150lbl.pdf 6/17/2014
AP06/16/2014S39581150   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s150ltr.pdf 6/18/2014
AP06/4/2014SLR39440155   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s155lbl.pdf 6/4/2014
AP06/4/2014SLR39448155   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s155ltr.pdf 6/5/2014
AP012/5/2014SE841181160   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s160ltr.pdf 12/9/2014
AP012/5/2014SE841205160   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s160lbl.pdf 12/10/2014
AP05/21/2015SLR42891162   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s162ltr.pdf 5/26/2015
AP06/8/2015SLR43021168   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s168ltr.pdf 6/10/2015
AP06/8/2015SLR43027168   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s168lbl.pdf 6/10/2015
AP02/26/2015SLR41952170   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s170ltr.pdf 3/2/2015
AP02/26/2015SLR41968170   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s170lbl.pdf 3/2/2015
AP04/8/2015SLR42490174   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s174lbl.pdf 4/10/2015
AP04/8/2015SLR42512174   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s174ltr.pdf 4/13/2015
AP03/2/2016SLR45374177   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s177ltr.pdf 3/4/2016
AP03/2/2016SLR45381177   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320Orig1s177lbl.pdf 3/4/2016
AP08/5/2016SLR46743178   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf 8/9/2016
AP08/5/2016SLR46755178   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf 8/9/2016




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