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FDA Drug Application 203496 by UNITED THERAP

Application Number203496
Application Type New Drug Application
Sponsor ApplicantUNITED THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2013N38139000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf 12/23/2013
AP012/20/2013N38161000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf 12/24/2013
AP012/20/2013N41182000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000TOC.cfm 12/9/2014
AP012/20/2013N41183000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf 12/9/2014
AP010/6/2014SCM40730001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf 10/8/2014
AP010/6/2014SCM40740001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf 10/9/2014
AP01/28/2016SE845041002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf 1/28/2016
AP01/28/2016SE845161002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf 2/11/2016
AP010/11/2016SCM       




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