dockets: FDA-2026-P-4918

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-4918 FDA Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312 Nonrulemaking 2026-05-06T18:12:44Z 0b000064b92c4e4d

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