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FDA Drug Application 021839 by IPSEN INC

Application Number021839
Application Type New Drug Application
Sponsor ApplicantIPSEN INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/30/2005N12667000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf 8/31/2005
AP08/30/2005N12753000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021839ltr.pdf 9/8/2005
AP08/30/2005N12867000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021839_IncrelexTOC.cfm 10/12/2005
AP02/16/2011SLR27926007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021839s007ltr.pdf 2/18/2011
AP02/16/2011SLR27947007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf 2/24/2011
AP09/13/2012SLR33753010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf 9/14/2012
AP09/13/2012SLR33767010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839Origs010ltr.pdf 9/17/2012
AP06/14/2012SLR32911012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839s012ltr.pdf 6/15/2012
AP06/14/2012SLR32932012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf 6/18/2012
AP01/16/2013SCM       
AP06/3/2014SLR39444016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf 6/4/2014
AP06/3/2014SLR39446016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021839Orig1s016ltr.pdf 6/5/2014
AP03/15/2016SLR45448017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021839Orig1s017ltr.pdf 3/16/2016
AP03/15/2016SLR45452017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf 3/17/2016




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