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ビジネス · 2014/4/21 分で読めます

Determination That NIMOTOP (Nimodipine) Capsules, 30 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

ローカル自動翻訳 · 情報源の原言語

概要

The Food and Drug Administration (FDA or Agency) has determined that NIMOTOP (Nimodipine) Capsules, 30 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug applications (ANDAs) that refer to nimodipine capsules, 30 mg, and it will allow FDA to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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