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FDA Drug Application 021463 by ENDO PHARMS

Application Number021463
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
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
AP012/29/2010N27483000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021463s000ltr.pdf 1/7/2011
AP012/29/2010N27492000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=20 1/7/2011
AP012/29/2010N27507000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021463s000lbl.pdf 1/11/2011
AP012/29/2010N27518000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239932.pdf 1/13/2011
AP012/29/2010N29999000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463_fortesta_toc.cfm 9/16/2011
AP012/29/2010N30000000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463Orig1s000SumR.pdf 9/16/2011
AP010/3/2016SCM       
AP09/9/2013SCM       
AP09/10/2013S37055010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021463Orig1s010ltr.pdf 9/11/2013
AP09/10/2013S37067010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021463s010lbl.pdf 9/11/2013
AP011/26/2013SCM       
AP03/24/2014SLR38900012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s012lbl.pdf 3/25/2014
AP03/24/2014SLR38902012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s012ltr.pdf 3/25/2014
AP06/4/2014SCM       
AP06/19/2014SLR39606014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s014ltr.pdf 6/23/2014
AP06/19/2014SLR39632014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf 6/23/2014
AP07/31/2014S40091015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s015ltr.pdf 8/1/2014
AP05/11/2015SLR42785017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021463Orig1s017ltr.pdf 5/13/2015
AP05/11/2015SLR42810017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf 5/13/2015
AP03/10/2016SCM       
AP010/25/2016SLR47476019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021463Orig1s019ltr.pdf 10/27/2016




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