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FDA Drug Application 022219 by ENDO PHARMS INC

Application Number022219
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS INC
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
AP03/5/2014N38683000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf 3/6/2014
AP03/5/2014N38686000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s000ltr.pdf 3/6/2014
AP03/5/2014N38782000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=313 3/13/2014
AP03/5/2014N45511000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022219Orig1AveedTOC.cfm 3/28/2016
AP06/19/2014SLR39609001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s001ltr.pdf 6/23/2014
AP06/19/2014SLR39629001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf 6/23/2014
AP03/3/2015SLR42010003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s003ltr.pdf 3/4/2015
AP03/3/2015SLR42032003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s003lbl.pdf 3/5/2015
AP05/11/2015SLR42787005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s005ltr.pdf 5/13/2015
AP05/11/2015SLR42807005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s005lbl.pdf 5/13/2015
AP08/11/2016SCM       
AP010/25/2016SLR47479009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s009ltr.pdf 10/27/2016




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