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FDA Drug Application 018044 by VALIDUS PHARMS

Application Number018044
Application Type New Drug Application
Sponsor ApplicantVALIDUS 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
AP08/17/1978N       
AP012/6/1978SCS       
AP011/9/1979SCS       
AP05/12/1980SCM       
AP012/10/1980SCS       
AP04/22/1982SLR       
AP011/4/1983SLR       
AP09/16/1986SCS       
AP08/20/1984SCP       
AP01/22/1986SES       
AP012/20/1985SCM       
AP05/16/1986SLR       
AP04/27/1988SCS       
AP04/27/1988SLR       
AP04/8/1991SLR3767018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf 5/6/1998
AP03/13/1990SCS3768019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf 5/6/1998
AP09/24/1991SCS       
AP09/24/1993SCS       
AP012/15/1995SCS       
AP05/26/1995SCS       
AP010/22/1996SLR3769024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf 5/6/1998
AP011/20/1998SE19393025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18044s25ltr.pdf 6/16/2004
AP04/27/1999SCM       
AP012/15/2000SCS       
AP02/1/2002SLR3220028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf 2/1/2002
AP010/15/2001SCM       
AP011/12/2001SCP       
AP07/7/2004SLR9728032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf 7/8/2004
AP02/22/2010SLR24909038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018044s038ltr.pdf 3/3/2010




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