The U.S. Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) for an injectable formulation of aminocaproic acid submitted by Zenara. The product is a prescription‑only injectable (route: INJECTION) with a strength of 250 mg/mL. The submission was classified as an original (ORIG) application, reviewed under standard priority, and received an approval status (AP) on 2025‑08‑28. This approval is identified by application number ANDA215374.
規制動向2026年9月12日•3分で読めます
FDA Approves Zenara’s Aminocaproic Acid Injection (ANDA215374)
The FDA has granted approval for Zenara’s aminocaproic acid injectable (250 mg/mL) under ANDA215374, classified as a prescription product.
Pharmacountryチームがまとめました · 出典： FDA.gov
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