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FDA Drug Application 017919 by JANSSEN PHARMS

Application Number017919
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
AP06/23/1977N       
AP03/29/1978SCS       
AP010/20/1977SCS       
AP07/31/1978SCS       
AP05/25/1978SCS       
AP04/17/1978SCS       
AP02/28/1978SCS       
AP02/28/1978SCS       
AP02/28/1978SCS       
AP06/19/1979SCF       
AP010/19/1979SCP       
AP011/8/1979SCS       
AP012/5/1979SLR       
AP012/5/1979SLR       
AP03/24/1980SCM       
AP08/21/1980SCM       
AP011/12/1980SCS       
AP011/12/1980SCS       
AP09/29/1982SLR       
AP06/9/1983SCS       
AP06/15/1983SLR       
AP09/29/1983SLR       
AP01/30/1984SLR       
AP06/21/1984SLR       
AP04/5/1985SLR       
AP010/21/1985SLR       
AP011/23/1987SCS       
AP02/26/1987SLR       
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       
AP01/4/1994SLR       
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       
AP01/6/1999SLR       
AP04/13/1998SCM       
AP04/28/1998SCM       
AP08/27/1999SLR       
AP01/5/2000SCP       
AP06/6/2000SLR       
AP07/9/2001SCS       
AP02/21/2002SCM       
AP06/3/2002SCS       
AP010/2/2013SLR37360086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf 10/4/2013
AP010/2/2013SLR37337086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf 10/4/2013
AP06/18/2012SLR32951089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 6/20/2012
AP06/18/2012SLR33188089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf 7/13/2012
AP010/2/2013SLR37348090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf 10/4/2013
AP010/2/2013SLR37332092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf 10/4/2013
AP010/2/2013SLR37354096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf 10/4/2013
AP09/11/2014SCM       
AP010/29/2015SLR44356099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf 11/4/2015
AP010/29/2015SLR44370099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf 11/4/2015




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