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FDA Drug Application 125390 by AEGERION

Application Number125390
Application Type Biologic License Application
Sponsor ApplicantAEGERION
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
AP02/24/2014N38581000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s000lbl.pdf 2/25/2014
AP02/24/2014N38598000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s000ltr.pdf 2/26/2014
AP02/24/2014N38765000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=314 3/12/2014
AP02/24/2014N39030000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000TOC.cfm 4/11/2014
AP02/24/2014N39031000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000SumR.pdf 4/11/2014
AP06/30/2014SLR39714004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s004ltr.pdf 7/1/2014
AP06/30/2014SLR39738004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf 7/2/2014
AP08/27/2015SLR43746006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf 8/28/2015
AP08/27/2015SLR43758006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s006ltr.pdf 9/1/2015
AP09/22/2015SLR43948010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s010ltr.pdf 9/23/2015
AP09/22/2015SLR44132010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf 10/6/2015




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