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FDA Drug Application 019892 by PURDUE PHARM PRODS

Application Number019892
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/7/1992N       
AP03/31/1995SLR       
AP03/10/2003SLR8916002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19891slr002,19892slr002ltr.pdf 6/2/2004
AP02/24/2000SCM       
AP08/22/2001SLR       
AP04/12/2001SCS       
AP04/12/2001SCS       
AP06/8/2006SLR14283009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019891s008, 019892s009LTR.pdf 6/12/2006
AP06/8/2006SLR14296009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf 6/12/2006
AP011/9/2007SCS18420015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf 11/19/2007
AP011/9/2007SCS18454015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019892s015ltr.pdf 11/19/2007
AP01/24/2013SCM       
AP012/18/2012SCM       
AP07/5/2013SCM       
AP01/26/2015SCM       




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