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FDA Drug Application 200535 by LEHIGH VALLEY

Application Number200535
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
AP010/20/2010N26726000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000MedGuide.pdf 10/21/2010
AP010/20/2010N26733000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200535s000ltr.pdf 10/25/2010
AP010/20/2010N26824000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000lbl.pdf 10/29/2010
AP010/20/2010N27964000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535s000_oxycodone_toc.cfm 2/24/2011
AP010/20/2010N27965000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535Orig1s000SumR.pdf 2/24/2011
AP01/25/2012SLR31576004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200535s004ltr.pdf 1/30/2012
AP08/22/2013SLR36886006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf 8/27/2013
AP08/22/2013SLR36955006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf 9/5/2013
AP010/8/2013SCM       
AP08/22/2013SCM36956008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf 9/5/2013
AP08/22/2013SCM36887008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf 8/27/2013
AP06/20/2014SCM39635009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200535s009lbl.pdf 6/23/2014
AP09/1/2015SCM       




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