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FDA Drug Application 202788 by INSYS THERAP

Application Number202788
Application Type New Drug Application
Sponsor ApplicantINSYS THERAP
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
AP01/4/2012N31353000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s000ltr.pdf 1/6/2012
AP01/4/2012N31363000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s000lbl.pdf 1/6/2012
AP01/4/2012N31625000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 2/1/2012
AP01/4/2012N32909000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM287863.pdf 6/15/2012
AP01/4/2012N33660000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788_subsys_toc.cfm 9/6/2012
AP01/4/2012N33661000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788Orig1s000SumR.pdf 9/6/2012
AP01/4/2012N36679000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM287863.pdf 8/5/2013
AP06/5/2012SLR32850001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf 6/7/2012
AP06/5/2012SLR32883001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf 6/11/2012
AP08/30/2012SLR33620002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf 8/31/2012
AP08/30/2012SLR33631002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788Orig1s002ltr.pdf 9/4/2012
AP06/5/2012SLR32851003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf 6/7/2012
AP06/5/2012SLR32882003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf 6/11/2012
AP07/31/2013SLR36685005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf 8/5/2013
AP07/31/2013SLR36755005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf 8/9/2013
AP07/31/2013SLR36686006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf 8/5/2013
AP07/31/2013SLR36756006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf 8/9/2013
AP012/24/2014SLR41464009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf 12/31/2014
AP012/24/2014SLR41560009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf 1/9/2015
AP011/7/2013SE837787010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s010ltr.pdf 11/12/2013
AP012/24/2014SCM41466011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf 12/31/2014
AP012/24/2014SCM41561011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf 1/9/2015
AP012/24/2014S41465012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf 12/31/2014
AP012/24/2014S41562012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf 1/9/2015
AP06/9/2015SCM       
AP02/12/2016SCM       




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