ビジネス · 2022/4/71 分で読めます
Determination That PEPCID (Famotidine) for Oral Suspension, 40 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we) has determined that PEPCID (famotidine) for oral suspension, 40 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 PEPCID (famotidine) for oral suspension, 40 mg/5 mL, if all other legal and regulatory requirements are met.