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FDA Drug Application 017463 by MCNEIL CONSUMER

Application Number017463
Application Type New Drug Application
Sponsor ApplicantMCNEIL CONSUMER
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
AP09/19/1974N24212000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088647.pdf 12/4/2009
AP011/11/1975SCS       
AP05/3/1976SCS       
AP011/12/1975SLR       
AP011/12/1975SCS       
AP011/12/1975SLR       
AP03/1/1976SLR       
AP05/3/1976SEF       
AP08/27/1976SLR       
AP09/8/1976SCM       
AP012/14/1976SDS       
AP08/21/1979SLR       
AP04/7/1977S       
AP02/3/1978SCE       
AP04/21/1978SCM       
AP02/23/1978SCS       
AP08/8/1978SCM       
AP02/9/1979SCS       
AP09/12/1978SCP       
AP02/27/1979SCE       
AP03/22/1979SCP       
AP08/21/1979SES       
AP04/16/1979SCM       
AP06/20/1979SCM       
AP01/31/1980SCS       
AP012/21/1979SCS       
AP03/1/1982SLR       
AP09/12/1980SCE       
AP03/31/1981SLR       
AP03/1/1982SLR       
AP07/2/1981SCE       
AP07/2/1981SCE       
AP03/1/1982SLR       
AP05/22/1985SLR       
AP04/9/1983SLR       
AP05/29/1984SCS       
AP05/22/1985SLR       
AP012/22/1986SCF       
AP010/31/1990SCF       
AP011/6/1985SLR       
AP010/10/1986SCP       
AP010/10/1986SLR       
AP010/10/1986SLR       
AP012/16/1986SCM       
AP011/27/1987SLR       
AP02/16/1988SLR       
AP02/16/1988SLR       
AP02/16/1988SLR       
AP010/2/1990SCS       
AP06/22/1994SCS       
AP07/25/1989SCM       
AP012/26/1990SCS       
AP010/19/1992SCM       
AP03/23/1995SCS       
AP011/15/1995SCS       
AP011/20/1995SCS       
AP07/20/1999SCM       
AP011/29/1999SCS       
AP06/20/2001SCM       
AP05/14/2001SCS       
AP01/24/2006SLR13489104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf 1/25/2006
AP01/24/2006SLR13522104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017463s104ltr.pdf 1/30/2006
AP09/10/2007SLR17837105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017463s105lbl.pdf 9/11/2007
AP09/10/2007SLR17862105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017463s105ltr.pdf 9/11/2007




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