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FDA Drug Application 017628 by ORTHO MCNEIL JANSSEN

Application Number017628
Application Type New Drug Application
Sponsor ApplicantORTHO MCNEIL JANSSEN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/24/1976N24193000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf 12/4/2009
AP07/23/1976SCM       
AP06/28/1976SCM       
AP07/23/1976SLR       
AP05/15/1979SCE       
AP02/21/1978SES       
AP04/6/1979SES       
AP03/13/1979SCP       
AP011/22/1981SLR       
AP01/18/1985SLR       
AP07/22/1982SCM       
AP09/19/1980SCM       
AP03/30/1981SCM       
AP07/12/1982SCM       
AP07/27/1982SCS       
AP06/16/1983SCM       
AP01/18/1985SLR       
AP012/11/1984SCM       
AP04/29/1988SE2       
AP01/18/1985SLR       
AP01/31/1983SLR       
AP01/31/1983SLR       
AP05/25/1983SCM       
AP03/8/1989SE2       
AP01/18/1985SLR       
AP05/3/1984SCS       
AP010/5/1984SCS       
AP02/7/1985SLR       
AP010/19/1988SCF       
AP012/11/1985SLR       
AP012/11/1985SLR       
AP012/11/1985SLR       
AP07/28/1989SCP       
AP07/31/1986SCP       
AP07/31/1986SCP       
AP012/2/1987SCP       
AP05/30/1989SCS       
AP05/30/1989SCS       
AP010/17/1989SCS       
AP08/17/1990SCS       
AP012/18/1989SCM       
AP01/21/1992SCS       
AP07/11/1991SCS       
AP03/25/1991SLR       
AP010/2/1992SCP       
AP01/21/1993SCS       
AP06/11/1993SCM       
AP03/4/1996SCM       
AP02/26/2001SCM       
AP03/21/2001SCM       
AP02/9/2006SLR13620067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf 2/22/2006
AP02/9/2006SLR13654067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018084s051,017628s067ltr.pdf 2/22/2006
AP01/22/2008SLR18942068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017628s068ltr.pdf 1/24/2008
AP01/22/2008SLR18952068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf 1/24/2008




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