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FDA Drug Application 205750 by RTRX

Application Number205750
Application Type New Drug Application
Sponsor ApplicantRTRX
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/17/2015N42189000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205750Orig1s000ltr.pdf 3/18/2015
AP03/17/2015N42193000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205750lbl.pdf 3/18/2015
AP03/17/2015N42513000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205750Orig1s000TOC.cfm 4/13/2015




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