dockets: FDA-2026-P-4800

Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

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id agency_id title docket_type last_modified object_id
FDA-2026-P-4800 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 Nonrulemaking 2026-05-04T17:21:12Z 0b000064b92c100b

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