この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2025/9/291 分で読めます
Determination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →