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FDA Drug Application 019697 by JANSSEN PHARMS

Application Number019697
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/3/1992N       
AP02/16/1995SCS21555002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/01969_s002_Orthotricyclen.pdf 1/12/2009
AP06/28/1994SLR       
AP012/28/1994SCM21589004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019697_s004_ORTHOTRICYCLEN.pdf 1/12/2009
AP01/29/1996SLR21590005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s005_ORTHOTRICYCLEN.pdf 1/12/2009
AP08/21/1995SCE       
AP08/21/1995SCS       
AP011/30/1995SCM       
AP02/7/1996SCS21591009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s009_ORTHOTRICYCLEN.pdf 1/12/2009
AP02/14/1996SCS21592010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s010_ORTHOTRICYCLEN.pdf 1/12/2009
AP08/2/1996SCS21593011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s011_ORTHO CYCLEN.pdf 1/12/2009
AP04/20/1998SLR       
AP08/21/1996SCS21594013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s013_ORTHOCYCLEN.pdf 1/12/2009
AP010/20/1999SCS21595015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s015_ORTHOCYCLEN.pdf 1/12/2009
AP011/2/1999SCM21596016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s016_ORTHOCYCLEN.pdf 1/12/2009
AP011/22/1999SLR21597018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s018_ORTHO CYCLEN.pdf 1/12/2009
AP09/30/1999SCM21598019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s019_ORTHOCYCLEN.pdf 1/12/2009
AP01/5/2000SCP21599021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019697_s021_ORTHO CYCLEN.pdf 1/12/2009
AP06/5/2000SLR       
AP01/16/2001SLR21600024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019697_s024_ORTHO CYCLEN.pdf 1/12/2009
AP08/30/2000SCE21601025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019697_s025_ORTHO CYCLEN.pdf 1/12/2009
AP07/9/2001SCS21602027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019697_s027_ORTHO CYCLEN.pdf 1/12/2009
AP01/16/2002SCM21603028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s028_ORTHO CYCLEN.pdf 1/12/2009
AP06/3/2002SCS21604029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s029_ORTHOCYCLEN.pdf 1/12/2009
AP09/6/2002SCM21605030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s030_ORTHOCYCLEN.pdf 1/12/2009
AP01/3/2003SCS21606032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019697_s032_ORTHOCYCLEN.pdf 1/12/2009
AP05/3/2007SLR16441034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf 5/7/2007
AP05/3/2007SLR16491034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019653s037,019697s034ltr.pdf 5/9/2007
AP05/30/2008SCF19920041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653s045,019697s041ltr.pdf 6/3/2008
AP010/2/2013SLR37363042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf 10/4/2013
AP010/2/2013SLR37876042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046, 019697Orig1s042lbl.pdf 11/20/2013
AP06/18/2012SLR32954044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 6/20/2012
AP06/18/2012SLR33191044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf 7/13/2012
AP010/2/2013SLR37351045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf 10/4/2013
AP010/2/2013SLR37335047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf 10/4/2013
AP010/2/2013SLR37340047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf 10/4/2013
AP010/2/2013SLR37357050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf 10/4/2013
AP05/1/2015SLR42717052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf 5/4/2015
AP05/1/2015SLR42721052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf 5/4/2015




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