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FDA Drug Application 022074 by IPSEN PHARMA

Application Number022074
Application Type New Drug Application
Sponsor ApplicantIPSEN PHARMA
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
AP08/30/2007N17738000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf 9/4/2007
AP08/30/2007N17742000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022074s000ltr.pdf 9/4/2007
AP08/30/2007N18305000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022074s000TOC.cfm 11/6/2007
AP03/4/2011SE228128003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf 3/7/2011
AP03/4/2011SE228175003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022074s003ltr.pdf 3/8/2011
AP010/28/2014SCM40893004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf 10/29/2014
AP011/27/2013SLR37960006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf 12/3/2013
AP011/27/2013SLR37964006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022074Orig1s006ltr.pdf 12/5/2013
AP02/21/2014SCM       
AP010/23/2014SCM       
AP012/22/2014SLR41403010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s010ltr.pdf 12/24/2014
AP012/22/2014SLR41589010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf 1/9/2015
AP012/16/2014S41259011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf 12/16/2014
AP012/16/2014S41279011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s011ltr.pdf 12/17/2014
AP06/1/2015SCM       
AP06/1/2015SCM       
AP011/2/2015SCM       
AP012/11/2015SCM       
AP09/9/2016SCM       




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