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FDA Drug Application 020973 by EISAI INC

Application Number020973
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/19/1999N789000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20973ltr.pdf 8/19/1999
AP08/19/1999N790000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20973_Aciphex.cfm 8/19/1999
AP08/19/1999N791000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf 8/19/1999
AP08/19/1999N31077000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP010/21/1999SCS       
AP02/16/2000SCM       
AP02/16/2000SCM       
AP05/8/2000SCM       
AP02/28/2000SCS       
AP09/20/2000SCP       
AP012/15/2000SCM       
AP08/15/2001SLR5487008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf 4/25/2003
AP08/15/2001SLR17002008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020973_S008_ACIPHEX_DELAYED_RELEASE_TABS.pdf 7/6/2007
AP02/12/2002SE12447009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s009ltr.pdf 2/12/2002
AP02/12/2002SE12448009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf 2/12/2002
AP02/12/2002SE131989009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020973Orig1s009.pdf 3/2/2012
AP010/2/2001SCS       
AP010/2/2001SCP       
AP05/29/2002SCF2446012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s012ltr.pdf 5/29/2002
AP011/8/2002SE84693013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-013ltr.pdf 11/8/2002
AP011/8/2002SE84694013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf 11/8/2002
AP011/8/2002SE85479013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm 4/25/2003
AP09/23/2002SLR1862014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973slr014ltr.pdf 9/23/2002
AP09/30/2002SCF1857015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973scf015ltr.pdf 9/30/2002
AP08/1/2003SLR6529016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20973slr016ltr.pdf 8/15/2003
AP06/3/2005SLR11750020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020973s020ltr.pdf 6/7/2005
AP06/3/2005SLR11768020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020973s020lbl.pdf 6/7/2005
AP06/30/2008SE520108022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf 6/30/2008
AP06/30/2008SE520151022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020973se5-022ltr.pdf 7/2/2008
AP06/30/2008SE520592022   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020973se022_SUMR.pdf 8/12/2008
AP09/3/2010SLR26420025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020973s025ltr.pdf 9/8/2010
AP09/3/2010SLR26465025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf 9/10/2010
AP05/20/2011SLR28935028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020973s028ltr.pdf 5/25/2011
AP05/20/2011SLR28967028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf 5/26/2011
AP010/5/2012SLR34014029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s029lbl.pdf 10/9/2012
AP010/5/2012SLR34015029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s029mg.pdf 10/9/2012
AP010/5/2012SLR34022029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973Orig1s029ltr.pdf 10/10/2012
AP05/8/2012SLR32673030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973s030ltr.pdf 5/10/2012
AP05/8/2012SLR32679030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s030lbl.pdf 5/10/2012
AP04/19/2013SLR35769032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020973Orig1s032ltr.pdf 4/23/2013
AP04/19/2013SLR35812032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf 4/23/2013
AP04/4/2016SLR45586033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s033lbledt.pdf 4/5/2016
AP04/4/2016SLR45591033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf 4/6/2016
AP04/4/2016SLR45784033   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM497380.pdf 4/27/2016
AP010/15/2014SLR40819034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf 10/16/2014
AP010/15/2014SLR40831034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf 10/21/2014
AP012/19/2014SLR41383035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf 12/24/2014
AP012/19/2014SLR41422035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf 12/29/2014
AP09/21/2016SCM       
AP010/24/2016SLR47450037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s037ltr.pdf 10/26/2016
AP010/24/2016SLR47512037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s037lbl.pdf 10/28/2016




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