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FDA Drug Application 020152 by BRISTOL MYERS SQUIBB

Application Number020152
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
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
AP012/22/1994N16518000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP03/28/1996SCM       
AP03/20/1996SCM       
AP06/25/1996SLR       
AP03/28/1996SCM       
AP02/6/1997SCM       
AP07/26/2000SLR17109006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020152_S006_SERZONE_AP.pdf 7/6/2007
AP01/13/1997SCS       
AP012/2/1996SCM       
AP05/5/1997SLR16549009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020152_s009s010_SERZONETOC.cfm 5/9/2007
AP05/5/1997SLR16550010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020152_s009s010_SERZONETOC.cfm 5/9/2007
AP03/31/1998SLR402011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20152sltr.pdf 3/31/1998
AP08/6/1997SLR       
AP01/27/1999SCM       
AP06/1/2000SLR       
AP06/1/2000SLR       
AP06/1/2000SLR       
AP09/23/1999SCM       
AP06/1/2000SLR       
AP09/9/1999SLR       
AP011/30/1999SCS       
AP04/10/2000SCM       
AP06/1/2000SLR       
AP011/9/2000SCM       
AP01/23/2001SLR       
AP03/21/2001SLR10907026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-152s026_Nefazodone.cfm 1/6/2005
AP03/21/2001SLR1619026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20152S26LTR.PDF 3/21/2001
AP03/11/2002SCS       
AP012/4/2001SLR3244028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20152s28ltr.pdf 12/4/2001
AP012/4/2001SLR17105028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020152_S028_SERZONE_AP.pdf 7/6/2007
AP01/8/2002SLR3243029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s29ltr.pdf 1/8/2002
AP04/23/2002SCM       
AP05/5/2003SLR5761031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20152slr031ltr.pdf 5/30/2003
AP05/5/2003SLR16551031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020152_s031_SERZONETOC.cfm 5/9/2007
AP06/20/2002SLR3242033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s033LTR.pdf 6/20/2002
AP05/27/2004SLR8830034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20152slr034ltr.pdf 6/1/2004
AP01/12/2005SLR10969035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20152s035ltr.pdf 1/13/2005
AP01/12/2005SLR10989035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20152s035lbl.pdf 1/13/2005




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