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FDA Drug Application 009165 by ENDO PHARMS

Application Number009165
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1953N       
AP07/15/1977SLR       
AP08/2/1979SES       
AP02/1/1980SES       
AP02/1/1980SES       
AP01/31/1984SLR       
AP07/31/1985SCM       
AP02/10/1987SCS       
AP05/5/1986SCS       
AP09/1/1987SCS       
AP09/1/1987SLR       
AP05/5/1989SCP       
AP012/9/1991SLR       
AP012/31/1997SCP       
AP012/14/1999SCS       
AP06/6/2002SCM       
AP03/7/2007SLR16034030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf 3/15/2007
AP03/7/2007SLR16042030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s030lbl.pdf 3/15/2007
AP07/25/2007SLR17381031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s031lbl.pdf 7/27/2007
AP07/25/2007SLR17417031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009165s031_ltr.pdf 7/30/2007
AP06/19/2014SLR39601032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009165Orig1s032ltr.pdf 6/23/2014
AP06/19/2014SLR39646032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009165s032lbl.pdf 6/23/2014
AP05/11/2015SLR42796033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009165Orig1s033ltr.pdf 5/13/2015
AP05/11/2015SLR42809033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009165s033lbl.pdf 5/13/2015
AP010/25/2016SLR47472034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009165Orig1s034ltr.pdf 10/27/2016




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