Nonrulemaking

Requests that the FDA declare that the drug product, Edaravone Powder for Oral Suspension 105 mg/Sachet is suitable for submission in an Abbreviated New Drug Application.

Documents

Total comments

all analyzed

Comment status

Open

Last activity

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In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

Supporting & Related Material· Aug 7, 2026
Attachment 1 - Orange Book→
Supporting & Related Material· Aug 7, 2026
Attachment 2 - RLD-Labeling→
Supporting & Related Material· Aug 7, 2026
Attachment 3 - Edaravone Powder for Oral Suspension PI revision→
Supporting & Related Material· Aug 7, 2026
Attachment 3 - Edaravone Powder for Oral Suspension PI revision - Track Changes→
Supporting & Related Material· Aug 7, 2026
Attachment 4 - Draft Guidance on Edaravone→