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FDA Drug Application 204242 by OREXO US INC

Application Number204242
Application Type New Drug Application
Sponsor ApplicantOREXO US INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/3/2013N36473000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf 7/5/2013
AP07/3/2013N36498000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s000ltr.pdf 7/8/2013
AP07/3/2013N36594000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 7/23/2013
AP07/3/2013N36600000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362203.pdf 7/24/2013
AP07/3/2013N39680000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204242Orig1s000TOC.cfm 6/27/2014
AP01/14/2014SCM       
AP09/4/2013S36988002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s002ltr.pdf 9/9/2013
AP012/11/2014SCM41232003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204242Orig1s003ltr.pdf 12/12/2014
AP012/11/2014SCM41760003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf 2/3/2015
AP08/10/2015SE843620004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s004ltr.pdf 8/11/2015
AP08/10/2015SE843625004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf 8/11/2015
AP02/12/2015S41850005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s005ltr.pdf 2/17/2015
AP06/4/2015SCM43011006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s006ltr.pdf 6/10/2015
AP06/4/2015SCM43023006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf 6/10/2015
AP010/4/2016S47294007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s007ltr.pdf 10/6/2016
AP010/4/2016S47309007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf 10/7/2016
AP07/7/2016S46490008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s008ltr.pdf 7/12/2016




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