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FDA Drug Application 018533 by JANSSEN PHARMS

Application Number018533
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)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/12/1981N36602000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf 7/25/2013
AP06/12/1981N38467000   http://www.fda.gov/drugs/drugsafety/ucm362415.htm 2/7/2014
AP09/29/1981SCM       
AP06/23/1983SLR       
AP06/30/1986SLR       
AP06/23/1983SLR       
AP04/15/1983SCM       
AP04/15/1983SCM       
AP09/8/1983SCS       
AP07/9/1984SCM       
AP07/9/1984SCM       
AP06/30/1986SLR       
AP06/30/1986SLR       
AP06/30/1986SLR       
AP06/30/1986SLR       
AP06/19/1985SCP       
AP05/10/1988SCE       
AP07/8/1988SCS       
AP04/14/1989SLR       
AP03/15/1991SLR       
AP012/28/1992SLR       
AP010/13/1992SCM       
AP012/28/1992SLR       
AP09/20/1993SCM       
AP03/22/1994SLR       
AP09/8/1995SCS       
AP09/8/1995SCM       
AP09/15/1995SCM       
AP07/8/1996SLR       
AP04/8/1996SCM       
AP06/14/1996SCS       
AP03/17/1998SCM       
AP05/28/1998SCS       
AP07/24/1998SCP       
AP04/13/1999SCM       
AP09/17/1999SCP       
AP04/1/2002SCS       
AP08/13/2002SCE       
AP07/25/2013SLR36601040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf 7/25/2013
AP07/25/2013SLR36636040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018533Orig1s040ltr.pdf 7/29/2013
AP02/25/2014SLR38607041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018533Orig1s041ltr.pdf 2/27/2014
AP02/25/2014SLR38666041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf 3/5/2014




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