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Public Timelines
FAQ

may 10, 2013 - FDA responded to a petition and the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.

Added to timeline:

13 Nov 2018
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Date:

may 10, 2013
Now
~ 13 years ago