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FDA Drug Application 019735 by JANSSEN PHARMS

Application Number019735
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP012/28/1990N23995000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088599.pdf 11/19/2009
AP02/28/1991SCS14084001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s001_FloxinTOC.cfm 5/10/2006
AP012/13/1991SCM14086004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s004_FloxinTOC.cfm 5/10/2006
AP05/15/1992SCS14087007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s007_FloxinTOC.cfm 5/10/2006
AP06/23/1992SCS14088008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s008_FloxinTOC.cfm 5/10/2006
AP09/20/1993SCS       
AP07/14/1992SCS14089016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s016_FloxinTOC.cfm 5/10/2006
AP012/8/1992SCM19615018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S018_Floxin.pdf 4/4/2008
AP09/10/1992SCF19616019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S019_Floxin.pdf 4/4/2008
AP08/11/1993SCM       
AP09/3/1992SCM19617022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S022_FLOXIN.pdf 4/4/2008
AP09/3/1992SCM19618023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S023_FLOXIN.pdf 4/4/2008
AP07/21/1994SLR       
AP011/30/1993SCM       
AP011/30/1993SCM       
AP011/30/1993SCM       
AP012/7/1993SCE       
AP01/9/1995SCM       
AP08/8/1994SCS       
AP09/11/1996SLR       
AP08/11/1997SLR       
AP09/22/1995SCP       
AP011/9/1995SCM       
AP012/19/1996SE1       
AP06/28/1996SCM       
AP09/21/1998SLR       
AP012/8/1999SLR       
AP03/25/1999SCM       
AP012/8/1999SLR       
AP09/8/1999SCM       
AP012/8/1999SLR       
AP010/30/2000SCS       
AP03/6/2004SLR7864051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735slr051ltr.pdf 3/10/2004
AP03/6/2004SLR8274051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735slr051_floxin_lbl.pdf 4/5/2004
AP09/15/2004SLR10217052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf 9/17/2004
AP09/15/2004SLR10222052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf 9/17/2004
AP09/15/2004SLR23324052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019735_S052_Floxin.pdf 9/16/2009
AP09/15/2004SLR10218053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf 9/17/2004
AP09/15/2004SLR10223053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf 9/17/2004
AP09/15/2004SLR23326053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019735_S053_floxin.pdf 9/16/2009
AP01/20/2006SLR13505054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s054LBL.pdf 1/27/2006
AP01/20/2006SLR13534054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s054ltr.pdf 1/30/2006
AP06/14/2006SLR14321055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s055lbl.pdf 6/20/2006
AP06/14/2006SLR14344055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s055LTR.pdf 6/20/2006
AP05/16/2007SLR16625056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s056ltr.pdf 5/29/2007
AP05/16/2007SLR16639056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s056lbl.pdf 5/29/2007
AP06/19/2007SLR16839057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s057lbl.pdf 6/27/2007
AP06/19/2007SLR16916057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s057ltr.pdf 7/5/2007
AP012/13/2007SLR18648058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s058lbl.pdf 12/14/2007
AP012/13/2007SLR18842058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s058ltr..pdf 1/9/2008
AP010/3/2008SLR20963059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019735s059ltr.pdf 10/7/2008
AP010/3/2008SLR21000059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019735s059lbl.pdf 10/9/2008
AP02/12/2009SLR21840060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019735s060ltr.pdf 2/13/2009
AP02/25/2011SLR28023061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019735s061ltr.pdf 3/3/2011
AP02/25/2011SLR28071061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf 3/4/2011
AP02/25/2011SLR28072061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061lbl.pdf 3/4/2011




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