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FDA Drug Application 018084 by ORTHO MCNEIL JANSSEN

Application Number018084
Application Type New Drug Application
Sponsor ApplicantORTHO MCNEIL JANSSEN
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
AP010/30/1979N24194000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf 12/4/2009
AP06/12/1981SCM       
AP012/21/1981SCP       
AP04/1/1981SCM       
AP07/12/1982SCM       
AP07/27/1982SCS       
AP01/18/1985SLR       
AP06/16/1983SCM       
AP01/15/1985SCM       
AP04/29/1988SE2       
AP01/31/1983SLR       
AP01/31/1983SLR       
AP05/25/1983SCM       
AP04/6/1983SCM       
AP01/18/1985SLR       
AP01/15/1985SCS       
AP05/3/1984SCS       
AP010/5/1984SCS       
AP02/7/1985SLR       
AP012/11/1985SLR       
AP012/11/1985SLR       
AP012/11/1985SLR       
AP07/31/1986SCP       
AP07/31/1986SCP       
AP012/2/1987SCP       
AP05/30/1989SCS       
AP05/30/1989SCS       
AP010/17/1989SCS       
AP012/18/1989SCM       
AP07/11/1991SCS       
AP03/25/1991SLR       
AP010/2/1991SCM       
AP01/21/1993SCS       
AP03/18/1993SCM       
AP03/4/1996SCM       
AP08/25/2000SCM       
AP012/19/2000SCM       
AP02/9/2006SLR13619051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf 2/22/2006
AP02/9/2006SLR13655051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018084s051,017628s067ltr.pdf 2/22/2006
AP01/22/2008SLR18943052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018084s052ltr.pdf 1/24/2008
AP01/22/2008SLR18953052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf 1/24/2008




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