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Zdrowie i gospodarka · 21.02.2012

Determination That REQUIP XL (Ropinerole Hydrochloride) Extended-Release Tablets, 3 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ropinerole hydrochloride extended- release tablets, 3 mg, if all other legal and regulatory requirements are met.

Source: Federal Register — Food and Drug AdministrationOpen original release →