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
Documents
7
Total comments
0
all analyzed
Comment status
Closed
Last activity
—
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
No documents mirrored for this docket yet.