Requests that FDA declare that an ANDA may be submitted for, Cyproheptadine 2 mg, a strength that differs from the currently approved RLD, Cyproheptadine Hydrochloride tablets from HERITAGE PHARMA LABS INC, which FDA approved in 4 mg strength prior to Jan 1st, 1982, under ANDA #087056.
🏛 Food and Drug Administration (FDA)FDA-2026-P-8559
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8
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0
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Open
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In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
- Other· Aug 4, 2026No comment period
- Supporting & Related Material· Aug 4, 2026
- Supporting & Related Material· Aug 4, 2026
- Supporting & Related Material· Aug 4, 2026
- Supporting & Related Material· Aug 4, 2026
- Supporting & Related Material· Aug 4, 2026
- Supporting & Related Material· Aug 4, 2026
