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FDA Drug Application 201532 by EISAI INC

Application Number201532
Application Type New Drug Application
Sponsor ApplicantEISAI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/15/2010N26958000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf 11/15/2010
AP011/15/2010N26985000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201532s000ltr.pdf 11/18/2010
AP011/15/2010N27417000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532s000_halaven_TOC.cfm 1/3/2011
AP011/15/2010N27897000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532Orig1s000SumR.pdf 2/17/2011
AP02/17/2012SLR31843004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf 2/22/2012
AP02/17/2012SLR31866004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201532s004ltr.pdf 2/23/2012
AP011/7/2012SCM       
AP08/22/2013SLR36880006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201532Orig1s006ltr.pdf 8/23/2013
AP08/22/2013SLR36885006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf 8/27/2013
AP09/27/2013SCM       
AP010/24/2013SCM       
AP08/1/2014SLR40116009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s009ltr.pdf 8/4/2014
AP08/1/2014SLR40120009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf 8/4/2014
AP012/19/2014SLR41398010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s010ltr.pdf 12/24/2014
AP012/19/2014SLR41587010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf 1/9/2015
AP04/10/2015SCM       
AP010/27/2015SLR44320013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201532s013ltr.pdf 10/28/2015
AP010/27/2015SLR44378013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf 11/4/2015
AP011/18/2015SCM       
AP01/28/2016SE845040015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf 1/28/2016
AP01/28/2016SE845046015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s015ltr.pdf 1/29/2016
AP010/19/2016SLR47414016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s016ltr.pdf 10/20/2016
AP010/19/2016SLR47418016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf 10/20/2016
AP07/21/2016SCM       




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