Requests that the FDA declare that the drug product Amiodarone Hydrochloride in Dextrose Injection, 720 mg/400 mL (1.8 mg/mL), is suitable for consideration in an Abbreviated New Drug Application
🏛 Food and Drug Administration (FDA)FDA-2026-P-0386
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
Supporting & Related MaterialJan 15, 2026
Attachment 1