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Kinh doanh · 12/12/20251 min read
Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Bản dịch tự động tại chỗ · Ngôn ngữ gốc của nguồn
Tóm tắt
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Ngôn ngữ gốc của nguồn: Federal Register — Food and Drug AdministrationĐọc bản gốc →