Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application.
🏛 Food and Drug Administration (FDA)FDA-2026-P-5194
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
Supporting & Related MaterialMay 11, 2026
Attachment 1