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Zdrowie i gospodarka · 7/5/2013

Determination That METADATE ER (Methylphenidate Hydrochloride) Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that METADATE ER (methylphenidate hydrochloride (HCl)) extended-release tablet, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate HCl extended-release tablet, 10 mg, if all other legal and regulatory requirements are met.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →