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FDA Drug Application 019927 by JANSSEN PHARMS

Application Number019927
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
AP08/31/1990N38469000   http://www.fda.gov/drugs/drugsafety/ucm362415.htm 2/7/2014
AP010/5/1990SCF       
AP03/6/1995SLR       
AP09/11/1992SCM       
AP07/2/1993SCS       
AP010/7/1993SCM       
AP011/2/1995SCS       
AP010/26/1995SCM       
AP011/2/1995SCM       
AP02/8/1996SCM       
AP011/2/1995SCM       
AP04/25/1996SLR       
AP05/30/1997SE1       
AP07/9/1996SCS       
AP010/10/1997SLR       
AP02/9/1998SCS       
AP05/26/1998SCS       
AP05/26/1998SCP       
AP02/1/1999SCP       
AP02/28/2002SCS       
AP05/6/2002SCS       
AP010/2/2002SCP       
AP08/7/2009SLR23386028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019927s028lbl.pdf 9/17/2009
AP012/4/2012SLR34549031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019927s031lbl.pdf 12/5/2012
AP012/4/2012SLR34560031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019927Orig1s031ltr.pdf 12/5/2012
AP010/29/2013SLR37617032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019927Orig1s032ltr.pdf 10/30/2013
AP010/29/2013SLR37643032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019927s032lbl.pdf 10/31/2013
AP06/5/2013SCM       
AP01/8/2014SCM       




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