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FDA Drug Application 201194 by VISTAPHARM

Application Number201194
Application Type New Drug Application
Sponsor ApplicantVISTAPHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/12/2012N31399000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201194s000ltr.pdf 1/17/2012
AP01/12/2012N31474000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201194s000lbl.pdf 1/23/2012
AP01/12/2012N31637000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM289880.pdf 2/3/2012
AP01/12/2012N33582000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194_oxycodone_toc.cfm 8/29/2012
AP01/12/2012N33583000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194Orig1s000SumR.pdf 8/29/2012
AP06/2/2014SCM       




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