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FDA Drug Application 125516 by UNITED THERAP

Application Number125516
Application Type Biologic License Application
Sponsor ApplicantUNITED THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/10/2015N42066000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf 3/10/2015
AP03/10/2015N42069000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125516Orig1s000ltr.pdf 3/10/2015
AP03/10/2015N42477000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000TOC.cfm 4/9/2015
AP03/10/2015N42478000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000SumR.pdf 4/9/2015




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