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FDA Drug Application 021778 by ENDO PHARMS INC

Application Number021778
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/5/2005N16871000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021778s000TOC.cfm 7/2/2007
AP07/5/2005N11942000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021778lbl.pdf 7/7/2005
AP07/5/2005N11958000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021778ltr.pdf 7/8/2005
AP03/19/2007SLR16080002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021778s002, 003ltr.pdf 3/23/2007
AP03/19/2007SLR16092002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf 3/23/2007
AP03/19/2007SCM16093003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf 3/23/2007
AP03/19/2007SCM16081003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021778s002, 003ltr.pdf 3/23/2007
AP08/12/2008SLR20616007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021778s007ltr.pdf 8/19/2008
AP07/21/2010SLR26025008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021778s008ltr.pdf 7/28/2010
AP07/21/2010SLR26054008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021778s008lbl.pdf 7/30/2010
AP01/25/2013SCM       
AP06/14/2013SCM       
AP03/17/2014SCM       
AP05/14/2013SLR36078016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021778Orig1s016ltr.pdf 5/16/2013
AP05/14/2013SLR36114016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021778s016lbl.pdf 5/21/2013
AP07/31/2014SCM       
AP09/18/2014SLR40530018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021778s018lbl.pdf 9/22/2014
AP09/18/2014SLR40552018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021778Orig1s018ltr.pdf 9/23/2014
AP010/16/2014SCM       
AP010/16/2014SCM       
AP011/5/2015SCM       




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