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FDA Drug Application 017577 by JANSSEN PHARMS

Application Number017577
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
AP07/16/1975N       
AP04/16/1976SLR       
AP04/2/1976SCP       
AP03/1/1977SCS       
AP010/21/1976SLR       
AP04/1/1977SCP       
AP012/5/1977SCS       
AP06/25/1979SLR       
AP012/22/1980SCP       
AP09/20/1982SLR       
AP01/7/1983SCP       
AP01/7/1983SCP       
AP01/7/1983SCP       
AP06/19/1985SCP       
AP06/11/1986SLR       
AP08/8/1986SCM       
AP010/23/1986SCS       
AP02/25/1988SLR       
AP04/29/1988SCS       
AP02/10/1989SLR       
AP011/27/1990SCS       
AP03/19/1991SLR       
AP012/26/1991SCS       
AP05/31/1996SCS       
AP07/9/1996SCS       
AP011/13/1997SCS       
AP02/20/1998SCS       
AP04/15/2003SE85320032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf 4/16/2003
AP04/15/2003SE823305032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017577_s032&s033_DITROPAN TABS.pdf 9/14/2009
AP04/15/2003SE823306033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017577_s032&s033_DITROPAN TABS.pdf 9/14/2009
AP04/15/2003SE85690033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf 5/29/2003
AP04/15/2003SE85319033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf 4/16/2003
AP02/6/2008SLR19082034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017577s034ltr.pdf 2/13/2008
AP02/6/2008SLR19115034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf 2/14/2008
AP07/13/2009SLR22976035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017577s035ltr.pdf 7/16/2009
AP07/13/2009SLR23045035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017577s035lbl.pdf 7/23/2009
AP08/8/2011SLR29728036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s036lbl.pdf 8/8/2011
AP08/8/2011SLR29732036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s036ltr.pdf 8/10/2011
AP012/15/2011SLR31088037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s037lbl.pdf 12/20/2011
AP012/15/2011SLR31104037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s037ltr.pdf 12/20/2011
AP03/22/2012SLR32176038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017577s038lbl.pdf 3/23/2012
AP03/22/2012SLR32185038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017577s038ltr.pdf 3/26/2012




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