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The product, is a reformulation of the original product, designed with physicochemical properties intended to make the drug resistant to physical and chemical manipulation for abuse by snorting and injecting.
While the reformulation was approved in 2011, the FDA determined that the drug did not meet the agency’s standards for being considered abuse-deterrent and therefore declined Endo’s request to include a description of abuse-deterrent properties in product labeling.
Endo replaced the original formulation of Opana ER with the new formulation in 2012, and petitioned the agency to determine that the original buy Opana ER was withdrawn from market due to safety concerns (which would result in withdrawing generic products referencing original Opana ER from the market).
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Methaqualone is a sedative and hypnotic medication. It was sold under the brand names Quaalude and Sopor among others, and sold as a combination drug under the brand name Mandrax which contained 250mg methaqualone and 25mg diphenhydramine within the same tablet.
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