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FDA Drug Application 200740 by SIGMA TAU

Application Number200740
Application Type New Drug Application
Sponsor ApplicantSIGMA TAU
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/2012N33961000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200740Orig1s000ltr.pdf 10/4/2012
AP010/2/2012N33975000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200740s000lbl.pdf 10/4/2012
AP010/2/2012N36883000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200740_cystaran_toc.cfm 8/26/2013
AP010/2/2012N36884000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200740Orig1s000SumR.pdf 8/26/2013




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