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FDA Drug Application 016636 by ADAPT

Application Number016636
Application Type New Drug Application
Sponsor ApplicantADAPT
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
AP04/13/1971N       
AP04/4/1975SCS       
AP04/4/1975SCS       
AP01/16/1975SLR       
AP06/5/1975SLR       
AP012/9/1974SDS       
AP06/6/1975SLR       
AP09/24/1975SLR       
AP04/8/1976SLR       
AP04/6/1976SLR       
AP010/20/1978SCS       
AP03/23/1979SLR       
AP011/30/1979SCM       
AP06/17/1980SCM       
AP06/23/1981SCM       
AP04/1/1981SCM       
AP09/30/1981SLR       
AP05/14/1981SCM       
AP05/14/1981SCP       
AP05/19/1982SCP       
AP07/23/1982SLR       
AP06/14/1982SCP       
AP06/23/1983SCP       
AP05/29/1992SE1       
AP011/17/1983SCM       
AP011/17/1983SCM       
AP07/23/1985SLR       
AP010/15/1984SCS       
AP09/25/1984SCM       
AP09/17/1984SCF       
AP09/17/1984SCF       
AP06/4/1986SCS       
AP06/4/1986SCS       
AP06/4/1986SCS       
AP06/4/1986SFP       
AP02/26/1987SCS       
AP010/20/1987SCS       
AP012/7/1987SCS       
AP06/15/1995SCS       
AP03/20/1995SCS       
AP02/11/2002SLR2890052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf 2/11/2002
AP02/11/2002SLR41953052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf 3/2/2015
AP09/6/1996SCS       
AP02/11/2002SLR2891054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf 2/11/2002
AP02/11/2002SLR41954054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf 3/2/2015
AP04/16/2002SCM       
AP01/15/2002SCS       
AP010/25/2002SCS       




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