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FDA Drug Application 203858 by AEGERION

Application Number203858
Application Type New Drug Application
Sponsor ApplicantAEGERION
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/21/2012N34778000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203858Orig1s000ltr_replace.pdf 12/27/2012
AP012/21/2012N34791000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=25 12/28/2012
AP012/21/2012N34801000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf 12/31/2012
AP012/21/2012N34818000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333530.pdf 1/3/2013
AP012/21/2012N35123000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/2038858_juxtapid_toc.cfm 2/11/2013
AP08/13/2013SLR36783001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s001ltr.pdf 8/15/2013
AP04/10/2013SLR35686002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s002ltr.pdf 4/16/2013
AP04/10/2013SLR35717002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf 4/16/2013
AP012/17/2013SCM       
AP04/23/2014SCM       
AP02/18/2014SLR38531006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s006ltr.pdf 2/19/2014
AP02/18/2014SLR38541006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf 2/19/2014
AP011/11/2014SCM       
AP08/8/2014SLR40199009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s009ltr.pdf 8/11/2014
AP08/8/2014SLR40209009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf 8/12/2014
AP04/23/2015SLR42650010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203858Orig1s010ltr.pdf 4/24/2015
AP04/23/2015SLR42654010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf 4/24/2015
AP04/24/2015SCM       
AP03/8/2016SLR45403012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s012ltr.pdf 3/10/2016
AP03/8/2016SLR45430012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf 3/14/2016
AP07/11/2016SCM       
AP05/23/2016SLR46138015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s015ltr.pdf 5/25/2016
AP05/23/2016SLR46146015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf 5/25/2016




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