FDA Federal Register (withdrawal of approval)·· 15 天前AI 评分48
FDA认定PEPCID RPD（法莫替丁）口腔崩解片20毫克和40毫克非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Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AI 导读
美国FDA发布通知，认定PEPCID RPD（法莫替丁）口腔崩解片20毫克和40毫克规格并非因安全性或有效性原因撤市。依据该认定，在其他法律和监管要求均满足的前提下，FDA可批准相应的法莫替丁口腔崩解片简略新药申请（ANDA）。
来源：FDA Federal Register (withdrawal of approval) · federalregister.gov