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FDA Drug Application 019034 by PURDUE PHARM PRODS

Application Number019034
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARM PRODS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/11/1984N       
AP02/29/1984SLR       
AP010/16/1991SCM       
AP010/16/1991SCP       
AP08/4/1994SLR       
AP08/8/1994SCS       
AP07/18/2001SLR       
AP011/9/2001SCS       
AP06/8/2006SLR14290012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019034s012LTR.pdf 6/12/2006
AP06/8/2006SLR14295012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf 6/12/2006
AP04/30/2009SE222441018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019034s018ltr.pdf 5/6/2009
AP04/30/2009SE222489018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf 5/11/2009
AP06/30/2011SLR29414021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019034s021ltr.pdf 7/6/2011
AP06/30/2011SLR29426021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf 7/6/2011




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