Nonrulemaking

Requests that the FDA declare that the drug product, Ergotamine Tartrate Sublingual Tablets 1 mg is suitable for submission in an Abbreviated New Drug Application.

Documents

Total comments

all analyzed

Comment status

Open

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In this docket

Documents

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

📄 Primary document

OtherJul 16, 2026

No comment period

Other· Jun 29, 2026
Suitability Petition from Senores Pharmaceuticals, Inc.→
No comment period
Other· Jun 29, 2026
Acknowledgement Letter from FDA DMB to Senores Pharmaceuticals, Inc.→
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Supporting & Related Material· Jun 29, 2026
Attachment 1→
Supporting & Related Material· Jun 29, 2026
Attachment 2→
Supporting & Related Material· Jun 29, 2026
Attachment 3→
Supporting & Related Material· Jun 29, 2026
Attachment 4→