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FDA Drug Application 020237 by EISAI INC

Application Number020237
Application Type New Drug Application
Sponsor ApplicantEISAI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/22/1994N       
AP04/18/1996SCS       
AP011/9/1995SCS9143002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf 6/7/2004
AP011/9/1995SCS       
AP011/9/1995SCS9142004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf 6/7/2004
AP09/27/1996SLR       
AP03/11/1997SLR       
AP02/11/1998SE15033007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen_appltr.pdf 2/11/1998
AP02/11/1998SE1363007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen.cfm 2/11/1998
AP06/10/2002SLR3223008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf 6/10/2002
AP06/10/2002SLR3224008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf 6/10/2002
AP06/10/2002SLR3225009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf 6/10/2002
AP06/10/2002SLR3226009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf 6/10/2002
AP02/4/2000SCM       
AP09/4/2002SCS       
AP04/18/2003SCS5500012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020237s012lbl.pdf 4/28/2003
AP04/18/2003SCS5710012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20237scs012ltr.pdf 5/29/2003
AP04/18/2003SCS17085012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020237_S012_SALAGEN_AP.pdf 7/6/2007
AP04/26/2013SCM       
AP09/10/2015SCM       




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