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FDA Drug Application 125387 by REGENERON PHARMACEUTICALS

Application Number125387
Application Type Biologic License Application
Sponsor ApplicantREGENERON PHARMACEUTICALS
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
AP011/18/2011N30668000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf 11/21/2011
AP011/18/2011N30723000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125387s000ltr.pdf 11/22/2011
AP011/18/2011N31375000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387s0000TOC.cfm 1/10/2012
AP011/18/2011N31376000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387Orig1s000SumR.pdf 1/10/2012
AP09/21/2012SE133816004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125387Orig1s004ltr.pdf 9/24/2012
AP09/21/2012SE133840004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125387s004lbl.pdf 9/25/2012
AP06/7/2013SLR36256015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125387Orig1s015,125387Orig1s020ltr.pdf 6/11/2013
AP06/7/2013SLR36265015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf 6/11/2013
AP06/7/2013SLR36267020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf 6/11/2013
AP06/7/2013SLR36257020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125387Orig1s015,125387Orig1s020ltr.pdf 6/11/2013
AP01/27/2014SLR38379023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s023ltr.pdf 1/28/2014
AP01/27/2014SLR38389023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s023lbl.pdf 1/28/2014
AP17/30/2015SLR43570036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125387Orig1s036ltr.pdf 8/4/2015
AP17/30/2015SLR43571036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s036lbl.pdf 8/4/2015
AP07/29/2014SE840078037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s037ltr.pdf 7/31/2014
AP010/6/2014SE840731043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s043ltr.pdf 10/8/2014
AP010/6/2014SE840741043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s043lbl.pdf 10/9/2014
AP03/25/2015SE842290048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125387Orig1s048ltr.pdf 3/26/2015
AP03/25/2015SE842296048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s048lbl.pdf 3/26/2015
AP05/24/2016SLR46149051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s051lbl.pdf 5/25/2016
AP05/24/2016SLR46150051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125387Orig1s051ltr.pdf 5/25/2016
AP010/24/2016SLR47443052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125387Orig1s052ltr.pdf 10/26/2016
AP010/24/2016SLR47525052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s052lbl.pdf 10/31/2016




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