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FDA Drug Application 020301 by JANSSEN PHARMS

Application Number020301
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/14/1992N       
AP01/5/1994SCM       
AP011/4/1993SCM       
AP06/2/1995SLR       
AP012/4/1996SCS       
AP02/21/1996SCM       
AP03/4/1996SCM       
AP02/14/1996SLR       
AP02/4/1997SLR       
AP011/19/1998SCS       
AP011/19/1998SCM       
AP03/3/1999SCM       
AP01/5/2000SCS       
AP06/19/2001SLR       
AP06/7/2001SCM       
AP02/21/2002SCM       
AP010/2/2013SLR37364025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf 10/4/2013
AP010/2/2013SLR37342025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf 10/4/2013
AP06/18/2012SLR32955027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 6/20/2012
AP06/18/2012SLR33192027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf 7/13/2012
AP010/2/2013SLR37352028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf 10/4/2013
AP010/2/2013SLR37341030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf 10/4/2013
AP04/8/2014SCM       
AP010/2/2013SLR37358034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf 10/4/2013
AP012/1/2015SLR44649036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020301Orig1s036ltr.pdf 12/2/2015
AP012/1/2015SLR44651036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf 12/2/2015




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