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FDA Drug Application 020966 by JANSSEN PHARMS

Application Number020966
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/1999N766000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20966ltr.pdf 3/30/1999
AP03/30/1999N767000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20966lbl.pdf 3/30/1999
AP03/30/1999N6483000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020996_sporanox_toc.cfm 8/13/2003
AP05/9/2001SLR5040001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 4/17/2001
AP05/9/2001SLR5041001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf 4/17/2001
AP05/9/2001SLR3302001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm 10/26/2001
AP010/25/1999SCS       
AP05/9/2001SLR3303003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm 10/26/2001
AP05/9/2001SLR5042003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 4/17/2001
AP05/9/2001SLR5044003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf 4/17/2001
AP05/9/2001SE15045004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 4/17/2001
AP05/9/2001SE15046004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf 4/17/2001
AP05/9/2001SE13304004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm 10/26/2001
AP02/28/2002SLR3297005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966s5ltr.pdf 2/28/2002
AP07/17/2002SLR3295006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966slr006ltr.pdf 7/17/2002
AP07/17/2002SLR3296006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20966s6lbl.pdf 7/17/2002
AP08/2/2002SCS       
AP08/2/2002SCM       
AP09/16/2002SCS       
AP010/10/2002SCS       
AP07/14/2004SLR9769011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20966s011ltr.pdf 7/21/2004
AP07/14/2004SLR9817011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20966s011lbl.pdf 7/21/2004
AP03/5/2009SLR21977017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf 3/10/2009
AP03/5/2009SLR22167017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf 4/3/2009
AP03/5/2009SLR22168018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf 4/3/2009
AP03/5/2009SLR21978018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf 3/10/2009
AP03/5/2009SLR21979020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf 3/10/2009
AP03/5/2009SLR22169020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf 4/3/2009
AP04/23/2009SLR22329022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s022ltr.pdf 4/27/2009
AP04/23/2009SLR22340022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s022lbl.pdf 4/28/2009




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