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FDA Drug Application 022387 by UNITED THERAP

Application Number022387
Application Type New Drug Application
Sponsor ApplicantUNITED THERAP
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
AP07/30/2009N23095000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf 7/30/2009
AP07/30/2009N23126000Usage Instructions  http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387UsageInstr.pdf 8/5/2009
AP07/30/2009N23138000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf 8/6/2009
AP07/30/2009N25227000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022387s000TOC.cfm 4/6/2010
AP02/8/2011SLR27799004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf 2/9/2011
AP02/8/2011SLR27829004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf 2/14/2011
AP01/7/2013SCM       
AP04/30/2013SLR35911008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf 5/1/2013
AP04/30/2013SLR35924008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf 5/2/2013
AP05/20/2014SE839341009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022387Orig1s009ltr.pdf 5/22/2014
AP05/20/2014SE839393009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf 5/28/2014
AP08/1/2014SLR       
AP06/23/2015SCM       
AP06/6/2016SLR46273014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022387Orig1s014ltr.pdf 6/8/2016
AP06/6/2016SLR46301014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf 6/13/2016




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