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FDA Drug Application 019813 by JANSSEN PHARMS

Application Number019813
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative; New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/7/1990N12415000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114961.htm 7/29/2005
AP08/7/1990N19174000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019813_ORIGINAL APPROVAL_PACKAGE.pdf 2/19/2008
AP08/7/1990N23949000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088584.pdf 11/18/2009
AP08/7/1990N33129000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP010/22/1990SCM       
AP010/22/1990SCM       
AP02/12/1991SCS       
AP07/5/1991SCM       
AP06/12/1991SCM       
AP07/28/1993SLR       
AP06/11/1993SCF       
AP010/25/1993SLR       
AP01/11/1994SLR       
AP06/19/1997SCS       
AP03/29/1994SLR       
AP011/7/1994SLR       
AP07/17/1997SLR17238018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S018_Duragesic.pdf 7/9/2007
AP07/17/1997SLR17237019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S019_Duragesic.pdf 7/9/2007
AP07/17/1997SLR17236020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S020_Duragesic.pdf 7/9/2007
AP07/17/1997SLR17235021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S021_Duragesic.pdf 7/9/2007
AP012/7/1999SCP       
AP04/11/2001SLR5004023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf 4/11/2001
AP04/11/2001SLR21609023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S023_DURAGESIC.pdf 1/12/2009
AP012/2/1999SCS       
AP011/1/2000SLR21610025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S025_DURAGESIC.pdf 1/12/2009
AP011/1/2000SLR21611026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S026_DURAGESIC.pdf 1/12/2009
AP04/26/2000SCS       
AP011/9/2000SCS       
AP011/9/2000SCS       
AP04/9/2001SLR5003030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf 4/11/2001
AP04/9/2001SLR21612030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S030_DURAGESIC.pdf 1/12/2009
AP02/7/2008SLR19092033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019813s033ltr.pdf 2/14/2008
AP02/7/2008SLR19111033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019813s033lbl.pdf 2/14/2008
AP02/7/2008SLR33770033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019813Orig1s033.pdf 9/17/2012
AP05/20/2003SE15799036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19813se1-036ltr.pdf 6/8/2003
AP05/20/2003SE15873036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19813se1-036_duragesic_lbl.pdf 6/8/2003
AP05/20/2003SE121613036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019813_S036_DURAGESIC.pdf 1/12/2009
AP02/4/2005SE211090039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19813s039ltr.pdf 2/8/2005
AP02/4/2005SE211092039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19813s039lbl.pdf 2/8/2005
AP02/4/2005SE221614039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019813_S039_DURAGESIC.pdf 1/12/2009
AP07/31/2009SLR25164044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf 4/1/2010
AP07/31/2009SLR34050044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019813Orig1s044.pdf 10/12/2012
AP07/9/2012SLR33130051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s051ltr.pdf 7/11/2012
AP07/9/2012SLR33141052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s052ltr.pdf 7/11/2012
AP07/9/2012SLR33160052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019813s052lbl.pdf 7/12/2012
AP012/19/2012SCM       
AP04/15/2013SLR35708056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s056ltr.pdf 4/16/2013
AP07/26/2013SCM       
AP09/23/2013SCM37204060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019813s060lblcorrection.pdf 9/24/2013
AP09/23/2013SCM37400060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s060ltr.pdf 10/9/2013
AP04/16/2014SLR39068063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019813s063lbl.pdf 4/16/2014
AP04/16/2014SLR39074063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s063ltr.pdf 4/17/2014
AP06/8/2014SCM       
AP08/19/2014S40269065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s065ltr.pdf 8/20/2014
AP06/26/2015S43224066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019813Orig1s066ltr.pdf 7/2/2015
AP04/20/2016S45716067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s067ltr.pdf 4/22/2016
AP09/30/2016S47264071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s071ltr.pdf 10/4/2016




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