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FDA Drug Application 020657 by JANSSEN PHARMS

Application Number020657
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/21/1997N       
AP02/20/1998SCS       
AP07/27/1998SCS       
AP07/27/1998SCP       
AP05/9/2001SLR3305004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm 10/26/2001
AP05/9/2001SLR5048004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 4/17/2001
AP05/9/2001SLR5049004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf 4/17/2001
AP05/9/2001SE13306005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm 10/26/2001
AP05/9/2001SE15050005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 4/17/2001
AP05/9/2001SE15052005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf 4/17/2001
AP04/25/2001SCS       
AP09/11/2002SLR3300007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf 9/11/2002
AP09/11/2002SLR3301007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf 9/11/2002
AP07/17/2002SLR3298008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20657slr008ltr.pdf 7/17/2002
AP07/17/2002SLR3299008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s8lbl.pdf 7/17/2002
AP010/10/2002SCS       
AP09/24/2003SLR6714010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20657slr010ltr.pdf 9/30/2003
AP09/24/2003SLR6715010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20657slr010_sporanox_lbl.pdf 9/30/2003
AP03/5/2009SLR21973011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf 3/10/2009
AP03/5/2009SLR22040011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf 3/17/2009
AP03/5/2009SLR21974018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf 3/10/2009
AP03/5/2009SLR22041018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf 3/17/2009
AP03/5/2009SLR21975019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf 3/10/2009
AP03/5/2009SLR22042019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf 3/17/2009
AP03/5/2009SLR21976021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf 3/10/2009
AP03/5/2009SLR22043021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf 3/17/2009
AP07/29/2010SLR26073024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020657s024lbl.pdf 7/31/2010
AP07/29/2010SLR26093024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf 8/3/2010
AP01/4/2011SLR27477025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020657s025ltr.pdf 1/7/2011
AP01/4/2011SLR27511025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s025lbl.pdf 1/11/2011
AP04/15/2011SLR28566026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s026lbl.pdf 4/18/2011
AP04/15/2011SLR28573026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020657s026ltr.pdf 4/19/2011
AP03/26/2012SLR32190027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s027lbl.pdf 3/27/2012
AP03/26/2012SLR32202027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020657s027,s028ltr.pdf 3/27/2012
AP03/26/2012SLR32191028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s028lbl.pdf 3/27/2012
AP03/26/2012SLR32203028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020657s027,s028ltr.pdf 3/27/2012
AP06/6/2013SCM       
AP06/9/2014SLR39466032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020657s032lbl.pdf 6/10/2014
AP06/9/2014SLR39512032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf 6/11/2014
AP04/16/2015SLR42562033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020083Orig1s058,020657Orig1s033ltr.pdf 4/17/2015
AP04/16/2015SLR42563033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf 4/17/2015




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