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FDA Drug Application 017118 by ENDO PHARMS

Application Number017118
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/20/1976N       
AP09/2/1977SDS       
AP010/27/1978SCM       
AP03/3/1986SLR       
AP04/11/1996SCS       
AP03/31/1999SCP       
AP06/29/1999SCE       
AP01/11/2002SCS       
AP09/4/2003SLR27421017Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017118_s017_Symmetrel_syrup.pdf 1/4/2011
AP09/4/2003SLR6708017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17118slr017ltr.pdf 9/29/2003
AP09/4/2003SLR8404017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf 4/27/2004
AP012/31/2008SLR21508019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017118s019ltr.pdf 1/6/2009
AP012/31/2008SLR21537019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf 1/6/2009




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