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FDA Drug Application 022058 by ENDO PHARM

Application Number022058
Application Type New Drug Application
Sponsor ApplicantENDO PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/3/2007N21307000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058_supprelin_la_toc.cfm 12/2/2008
AP05/3/2007N21308000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058s000_SumR.pdf 12/2/2008
AP05/3/2007N16443000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022058lbl.pdf 5/7/2007
AP05/3/2007N16487000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022058s000ltr.pdf 5/9/2007
AP011/21/2007SLR18585001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022058s001ltr.pdf 11/26/2007
AP07/2/2008SCP20161003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022058s003ltr.pdf 7/8/2008
AP07/2/2008SCP20170003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022058s003lbl.pdf 7/9/2008
AP010/30/2011SLR30460006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022058s006ltr.pdf 11/2/2011
AP010/30/2011SLR30653006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022058s006lbl.pdf 11/18/2011
AP06/19/2013SCM46512008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s008lbl.pdf 7/13/2016
AP04/5/2012SLR32362009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022058s009ltr.pdf 4/6/2012
AP04/5/2012SLR32363009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022058s009lbl.pdf 4/6/2012
AP04/2/2013SLR35628011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022058Orig1s011ltr.pdf 4/3/2013
AP04/2/2013SLR35653011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s011lbl.pdf 4/9/2013
AP04/21/2015SCM       




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