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FDA Drug Application 018985 by JANSSEN PHARMS

Application Number018985
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
AP04/4/1984N       
AP06/21/1984SLR       
AP04/5/1985SLR       
AP010/21/1985SLR       
AP011/23/1987SCS       
AP02/2/1987SLR       
AP09/9/1988SLR       
AP06/8/1988SCM       
AP010/28/1988SCS       
AP07/19/1989SLR       
AP010/23/1989SLR       
AP01/18/1990SCS       
AP09/16/1991SLR       
AP03/18/1991SCS       
AP03/7/1994SCF       
AP05/18/1993SCS       
AP01/3/1994SLR       
AP011/4/1993SCM       
AP02/16/1995SCS       
AP09/7/1995SCS       
AP011/30/1995SCM       
AP05/10/1996SCS       
AP04/9/1996SCS       
AP01/29/1997SCS       
AP02/24/1997SCS       
AP08/27/1999SLR       
AP08/27/1999SLR       
AP04/13/1998SCM       
AP04/28/1998SCM       
AP08/27/1999SLR       
AP01/5/2000SCP       
AP06/6/2000SLR       
AP07/9/2001SCS       
AP02/21/2002SCM       
AP06/3/2002SCS       
AP010/2/2013SLR37338050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf 10/4/2013
AP010/2/2013SLR37361050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf 10/4/2013
AP06/18/2012SLR32952053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 6/20/2012
AP06/18/2012SLR33189053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf 7/13/2012
AP010/2/2013SLR37349054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf 10/4/2013
AP010/2/2013SLR37333056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf 10/4/2013
AP010/2/2013SLR37355060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf 10/4/2013
AP09/11/2014SCM       
AP010/29/2015SLR44357063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf 11/4/2015
AP010/29/2015SLR44369063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf 11/4/2015




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