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FDA Drug Application 125166 by ALEXION PHARM

Application Number125166
Application Type Biologic License Application
Sponsor ApplicantALEXION PHARM
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
AP03/16/2007N160630000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125166lbl.pdf 3/23/2007
AP03/16/2007N161020000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125166s0000_LTR.pdf 3/27/2007
AP03/16/2007N165790000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/125166s0000TOC.cfm 5/17/2007
AP03/16/2007N167610000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089130.pdf 6/14/2007
AP03/16/2007N258780000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=49 6/30/2010
AP06/30/2008S231440033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125166s0033ltr.pdf 8/7/2009
AP06/4/2010S25852044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125166s044ltr.pdf 6/29/2010
AP09/23/2011S30067172   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf 9/23/2011
AP09/23/2011S43420172   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125166Orig1s172-2.pdf 7/20/2015
AP012/21/2012SLR34776273   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125166Orig1s273ltr.pdf 12/27/2012
AP04/30/2014SE839192368   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166Orig1s380ltr.pdf 5/2/2014
AP04/30/2014SE839199368   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf 5/2/2014
AP04/30/2014SLR39193380   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166Orig1s380ltr.pdf 5/2/2014
AP04/30/2014SLR39200380   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf 5/2/2014
AP010/10/2014S40761409   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s409ltr.pdf 10/14/2014
AP012/3/2015SLR44679412   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413ltr.pdf 12/8/2015
AP012/3/2015S44680413   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413ltr.pdf 12/8/2015
AP012/3/2015S44699413   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125166s413lbl.pdf 12/8/2015
AP04/13/2016S45688414   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125166Orig1s414ltr.pdf 4/15/2016




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