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Metadate ER Not Withdrawn for S&E

07/08/2013

Federal Register Notice: FDA has determined that Metadate ER (methylphenidate hydrochloride) extended-release tablet, 10 mg was not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to approve ANDAs for methylphenidate HCl extended-release tablet, 10 mg, if all other legal and regulatory requirements are met. To view this notice, click here.

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