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FDA Drug Application 205383 by INTERPHARMA PRAHA AS

Application Number205383
Application Type New Drug Application
Sponsor ApplicantINTERPHARMA PRAHA AS
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
AP03/26/2015N42412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205383Orig1s000ltr.pdf 4/3/2015
AP03/26/2015N42615000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205383Orig1s000TOC.cfm 4/22/2015
AP03/26/2015N42621000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205383Orig1s000SumR.pdf 4/22/2015
AP03/26/2015N42683000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205383s000lbl.pdf 4/28/2015




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