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FDA Drug Application 005213 by ENDO PHARMS

Application Number005213
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/23/1943N       
AP07/26/1988SE1       
AP07/26/1988SCS       
AP07/26/1988SPD       
AP012/23/1988SCS       
AP011/8/1988SCM35263023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005213Orig1s023.pdf 2/27/2013
AP04/22/1992SCS       
AP07/10/2000SCP       
AP04/23/1999SCS       
AP06/15/2001SCM       
AP01/16/2002SCS       
AP01/26/2009SLR21695037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005213s037ltr.pdf 1/30/2009
AP01/26/2009SLR21744037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005213s037lbl.pdf 2/4/2009




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