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FDA Drug Application 201655 by ENDO PHARMS

Application Number201655
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/9/2011N33550000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655_opana_er_toc.cfm 8/27/2012
AP012/9/2011N33551000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655Orig1s000SumR.pdf 8/27/2012
AP012/9/2011N31305000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201655Orig1s000Ltr.pdf 12/9/2011
AP012/9/2011N31306000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201655lbl.pdf 12/9/2011
AP012/9/2011N31352000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 1/5/2012
AP012/9/2011N33137000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM283820.pdf 7/11/2012
AP07/9/2012SLR33146002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201655Orig1s002ltr.pdf 7/11/2012
AP07/9/2012SLR33163002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201655s002lbl.pdf 7/12/2012
AP01/14/2013SLR34886004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201655s004lbl.pdf 1/14/2013
AP01/14/2013SLR34893004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s004ltr.pdf 1/16/2013
AP04/15/2013SLR35745005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s005ltr.pdf 4/18/2013
AP05/13/2013SCM       
AP05/29/2013SCM       
AP012/5/2013SLR       
AP04/16/2014SLR39058012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201655s012lbl.pdf 4/16/2014
AP04/16/2014SLR39081012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201655Orig1s012ltr.pdf 4/17/2014
AP05/15/2014SCM       
AP09/23/2014SCM       
AP08/19/2014S40278015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201655Orig1s015ltr.pdf 8/20/2014
AP01/28/2015SLR41714016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s016ltr.pdf 1/29/2015
AP01/28/2015SLR41743016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201655s016lbl.pdf 1/30/2015
AP01/28/2015SLR45547016   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM493175.pdf 3/30/2016
AP06/26/2015S43263017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s017ltr.pdf 7/7/2015
AP08/24/2015SCM       
AP02/22/2016SCM       
AP04/20/2016S45734020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s020ltr.pdf 4/22/2016
AP09/30/2016S47259022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s022ltr.pdf 10/3/2016




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