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01/17/17 10:11 AM

#239312 RE: jour_trader #239310

$ELTP ANDA Oxycontin would have to have the exact or better ADF properties as Pudue's NDA Oxycontin as a requirement for FDA BE approval.

The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).



http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm