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FDA Drug Application 203567 by DOW PHARM

Application Number203567
Application Type New Drug Application
Sponsor ApplicantDOW PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/6/2014N39457000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203567Orig1s000ltr.pdf 6/10/2014
AP06/6/2014N39478000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203567s000lbl.pdf 6/10/2014
AP06/6/2014N39727000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm 7/2/2014
AP06/6/2014N39747000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000SumR.pdf 7/3/2014
AP02/27/2015SLR41975002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203567Orig1s002ltr.pdf 3/2/2015
AP02/27/2015SLR42224002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf 3/20/2015
AP08/26/2015SCM       
AP011/5/2015SCM       
AP04/1/2016SCM       
AP09/22/2016SLR47175006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf 9/27/2016
AP09/22/2016SLR47332006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203567Orig1s006ltr.pdf 10/12/2016




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