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FDA Drug Application 019653 by JANSSEN PHARMS

Application Number019653
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); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1989N       
AP09/30/1993SLR       
AP05/23/1991SCS       
AP09/17/1991SLR       
AP06/24/1992SCM       
AP010/1/1992SCS       
AP02/16/1995SCS       
AP011/4/1993SCM       
AP06/28/1994SLR       
AP01/29/1996SLR       
AP08/21/1995SCS       
AP011/30/1995SCM       
AP02/14/1996SCS       
AP08/2/1996SCS21575016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019653_s016_ORTHO CYCLEN.pdf 1/12/2009
AP04/20/1998SLR21576017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019653_s017_ORTHOCYCLEN.pdf 1/12/2009
AP08/21/1996SCS21577018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019653_s018_ORTHO CYCLEN.pdf 1/12/2009
AP010/20/1999SCS21578020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s020_ORTHOCYCLEN.pdf 1/12/2009
AP011/2/1999SCM21579021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s021_ORTHOCYCLEN.pdf 1/12/2009
AP011/22/1999SLR21580022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s022_ORTHO CYCLEN.pdf 1/12/2009
AP09/30/1999SCM21581023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s023_ORTHOCYCLEN.pdf 1/12/2009
AP01/5/2000SCP21582024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019653_s024_ORTHO CYCLEN.pdf 1/12/2009
AP06/5/2000SLR       
AP01/16/2001SLR21583027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s027_ORTHO CYCLEN.pdf 1/12/2009
AP07/9/2001SCS21584030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s030_ORTHO CYCLEN.pdf 1/12/2009
AP01/16/2002SCM21585031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s031_ORTHO CYCLEN.pdf 1/12/2009
AP06/3/2002SCS21586032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s032_ORTHOCYCLEN.pdf 1/12/2009
AP09/6/2002SCM21587033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s033_ORTHOCYCLEN.pdf 1/12/2009
AP01/3/2003S21588035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019653_s035_ORTHOCYCLEN.pdf 1/12/2009
AP05/3/2007SLR16442037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf 5/7/2007
AP05/3/2007SLR16493037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019653s037,019697s034ltr.pdf 5/9/2007
AP05/30/2008SCF19921045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653s045,019697s041ltr.pdf 6/3/2008
AP010/2/2013SLR37334046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf 10/4/2013
AP010/2/2013SLR37362046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf 10/4/2013
AP06/18/2012SLR32953048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 6/20/2012
AP06/18/2012SLR33190048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf 7/13/2012
AP010/2/2013SLR37350049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf 10/4/2013
AP010/2/2013SLR37339051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf 10/4/2013
AP010/2/2013SLR37356054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf 10/4/2013
AP05/1/2015SLR42716056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf 5/4/2015
AP05/1/2015SLR42720056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf 5/4/2015
AP06/22/2016SCM       




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