FDA 认定 PEPCID RPD（法莫替丁）20 mg 与 40 mg 口崩片未因安全性或有效性原因撤市
Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA 作出认定，PEPCID RPD（法莫替丁）20 mg 与 40 mg 口崩片并非因安全性或有效性原因撤出销售。该认定意味着上述规格产品可继续作为参比制剂用于仿制药开发与审批。
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来源：Federal Register · FDA · federalregister.gov