精选行业洞察美国 FDAT1067
Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
🤖 AI 摘要
The Food and Drug Administration (FDA or Agency) has determined that VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/50 milliliters (mL) (1 unit/mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/ 50 mL (1 unit/mL), if all other legal and regulatory requirements are met.
分析模型:rule-based-v3 · 07-09 06:59
评分详情
综合分 67/100
信源权威
95
影响范围
70
时效性
80
合规紧急
40
行业关注
35
Federal Register: FDA Notices (官方通知)
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