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FDA Drug Application 008085 by DAVA PHARMS INC

Application Number008085
Application Type New Drug Application
Sponsor ApplicantDAVA PHARMS INC
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
AP012/7/1953N       
AP01/26/1976S       
AP04/29/1977SCP       
AP04/29/1977SLM       
AP05/1/1979SCS       
AP07/10/1978SCS       
AP09/5/1979SCF       
AP02/4/1983SCF       
AP08/4/1983SCS       
AP04/4/1984SCS       
AP07/19/1984SCS       
AP010/31/1988SCP       
AP010/31/1988SE1       
AP09/16/1986SLR       
AP012/8/1986SCM       
AP01/18/1990SLR       
AP011/16/1989SCM       
AP04/24/1989SLR       
AP05/18/1989SCS       
AP010/24/1990SCS       
AP07/24/1991SLR       
AP010/5/1990SCS       
AP05/20/1997SLR       
AP011/8/2000SLR       
AP06/18/1998SCM       
AP010/29/1999SLR       
AP02/9/2000SCP       
AP05/8/2001SLR       
AP010/24/2003SLR6865052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf 11/5/2003
AP010/24/2003SLR6881052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf 11/5/2003
AP02/20/2002SLR4773053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf 2/20/2002
AP02/20/2002SLR3653054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf 2/20/2002
AP010/24/2003SCM6879055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf 11/5/2003
AP010/24/2003SCM6880055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf 11/5/2003
AP05/31/2006SLR14213058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/008085s058LTR.pdf 6/2/2006
AP012/2/2015SCM       
AP01/29/2016SLR45058066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008085Orig1s066ltr.pdf 2/1/2016
AP01/29/2016SLR45184066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf 2/18/2016




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