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FDA Drug Application 204958 by CHIESI USA INC

Application Number204958
Application Type New Drug Application
Sponsor ApplicantCHIESI USA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/22/2015N43097000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204958Orig1s000ltr.pdf 6/22/2015
AP06/22/2015N43100000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958lbl.pdf 6/22/2015
AP06/22/2015N43518000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204958Orig1s000TOC.cfm 7/29/2015
AP06/22/2015N43519000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204958Orig1s000SumR.pdf 7/29/2015
AP03/2/2016SCM       




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