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FDA Drug Application 202057 by AMARIN PHARMS

Application Number202057
Application Type New Drug Application
Sponsor ApplicantAMARIN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/26/2012N33287000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202057Orig1s000ltr.pdf 7/30/2012
AP07/26/2012N33314000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202057S000lbl.pdf 7/30/2012
AP07/26/2012N35350000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057_vascepa_toc.cfm 3/6/2013
AP07/26/2012N35351000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000SumR.pdf 3/6/2013
AP01/31/2013SCM35049001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s001ltr.pdf 2/4/2013
AP03/20/2013SCM35539002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf 3/26/2013
AP04/12/2013SCM       
AP04/19/2013SCM       
AP02/13/2014SCM38524006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202057Orig1s006ltr.pdf 2/14/2014
AP02/13/2014SCM38529006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202057Orig1s006lbl.pdf 2/14/2014
AP07/28/2014SCM       
AP02/26/2014SCM       
AP011/25/2013SLR37935009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf 11/26/2013
AP011/25/2013SLR37949009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf 11/27/2013
AP08/14/2014SCM       
AP010/16/2014SCM       
AP06/23/2015SCM43112012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202057s012lbl.pdf 6/24/2015
AP08/4/2015SCM       
AP010/2/2015SCM       
AP01/28/2016SCM       
AP01/25/2016SCM       
AP010/14/2016SCM       




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