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FDA Drug Application 200534 by LEHIGH VALLEY

Application Number200534
Application Type New Drug Application
Sponsor ApplicantLEHIGH VALLEY
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
AP010/20/2010N26727000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf 10/21/2010
AP010/20/2010N26770000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200534s000ltr.pdf 10/26/2010
AP010/20/2010N27962000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534s000_oxycodone_toc.cfm 2/24/2011
AP010/20/2010N27963000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534Orig1s000SumR.pdf 2/24/2011
AP06/2/2014SCM       
AP011/16/2015SCM       




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