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FDA Drug Application 018709 by APOTHECON

Application Number018709
Application Type New Drug Application
Sponsor ApplicantAPOTHECON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/12/1984N       
AP011/20/1984SCS       
AP02/7/1985SCP       
AP08/1/1985SCP       
AP07/3/1985SCP       
AP011/10/1986SCS       
AP07/15/1985SCP       
AP08/2/1985SLR       
AP01/17/1986SLR       
AP010/24/1991SE1       
AP01/6/1987SCP       
AP010/6/1987SCS       
AP06/22/1988SLR       
AP010/19/1989SLR       
AP05/3/1989SLR       
AP09/27/1990SLR       
AP03/21/1991SLR       
AP09/5/1990SCP       
AP012/10/1991SCM       
AP03/5/1992SCP       
AP07/25/1994SLR       
AP06/25/1992SLR       
AP010/15/1992SLR       
AP05/12/1993SCP       
AP010/6/1995SCM       
AP07/31/1996SLR       
AP07/31/1996SLR       
AP03/4/1996SCS       
AP06/26/1996SCM       
AP06/3/1998SLR       
AP05/20/1997SCS       
AP05/16/2006SLR14141033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018709s033LTR.pdf 5/21/2006
AP02/26/2009SLR21927035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018709s035ltr.pdf 3/3/2009




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