Back to FDA Applications sponsored by JANSSEN PHARMS

FDA Drug Application 020083 by JANSSEN PHARMS

Application Number020083
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 Priority*
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/11/1992N       
AP010/13/1992SCM       
AP012/28/1992SLR       
AP06/9/1993SCM       
AP03/29/1994SE1       
AP05/9/1994SCM       
AP011/9/1993SLR       
AP010/12/1994SCM       
AP09/8/1995SCM       
AP09/15/1995SCM       
AP05/23/1996SLR       
AP03/22/1996SCM       
AP012/10/1996SLR       
AP08/6/1997SLR       
AP08/6/1997SLR       
AP011/3/1997SCS       
AP07/27/1998SCS       
AP07/27/1998SCP       
AP02/17/1999SCS       
AP09/29/1999SCP       
AP05/9/2001SLR5449025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20083s25lbl.pdf 4/24/2003
AP03/21/2001SCE       
AP02/27/2002SCS       
AP07/17/2002SLR3289028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf 7/17/2002
AP07/17/2002SLR3290028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf 7/17/2002
AP04/11/2002SLR3293029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083s29ltr.pdf 4/11/2002
AP04/11/2002SLR3294029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf 4/11/2002
AP010/10/2002SCS       
AP07/17/2002SLR3291031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf 7/17/2002
AP07/17/2002SLR3292031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf 7/17/2002
AP011/10/2003SLR6934033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20083slr033ltr.pdf 11/25/2003
AP011/10/2003SLR7018033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20083slr033_sporanox_lbl.pdf 12/2/2003
AP07/14/2004SLR9782034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf 7/21/2004
AP07/14/2004SLR9783034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf 7/21/2004
AP07/14/2004SLR9811034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf 7/21/2004
AP07/14/2004SLR9784035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf 7/21/2004
AP07/14/2004SLR9812035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf 7/21/2004
AP03/5/2009SLR21970040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf 3/10/2009
AP03/5/2009SLR22035040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf 3/17/2009
AP03/5/2009SLR21971041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf 3/10/2009
AP03/5/2009SLR22036041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf 3/17/2009
AP03/5/2009SLR21972044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf 3/10/2009
AP03/5/2009SLR22037044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf 3/17/2009
AP07/29/2010SLR26072046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf 7/31/2010
AP07/29/2010SLR26092046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf 8/3/2010
AP04/18/2012SLR32490048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf 4/20/2012
AP04/18/2012SLR32499048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf 4/23/2012
AP04/18/2012SLR32491049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf 4/20/2012
AP04/18/2012SLR32500049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf 4/23/2012
AP04/18/2012SLR32492050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf 4/20/2012
AP04/18/2012SLR32501050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf 4/23/2012
AP03/1/2013SCM       
AP06/5/2013SCM       
AP06/9/2014SLR39465053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf 6/10/2014
AP06/9/2014SLR39511053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf 6/11/2014
AP04/11/2014SCM       
AP06/13/2014SCM       
AP04/16/2015SLR42561058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020083Orig1s058,020657Orig1s033ltr.pdf 4/17/2015
AP04/16/2015SLR42564058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf 4/17/2015
AP09/29/2016SCM       




Back to FDA Applications sponsored by JANSSEN PHARMS