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FDA Drug Application 008816 by OAK PHARMS

Application Number008816
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/12/1953N       
AP03/6/1973SLR       
AP02/2/1977SLR       
AP01/12/1977SCS       
AP02/2/1977SLR       
AP02/16/1979SCP       
AP02/23/1981SES       
AP02/23/1981SLR       
AP011/20/1984SPD       
AP03/25/1982SCS       
AP07/11/1984SCF       
AP07/11/1984SLR       
AP06/20/1984SCM       
AP09/16/1987SCM       
AP06/8/1987SCS       
AP06/8/1987SCP       
AP011/7/1990SCP       
AP02/18/1993SCM       
AP04/7/1998SCP       
AP05/31/1996SCM       
AP07/29/1999SCP       
AP06/2/2000SCP       
AP07/23/2004SLR9866032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08816s032ltr.pdf 7/28/2004
AP07/23/2004SLR9867032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf 7/28/2004
AP011/28/2012SCM       
AP09/24/2013SCM       
AP010/24/2013SCM       




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