dockets: FDA-2026-P-4762

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-4762 FDA Requests that the FDA Require ANDA 220582 to be supported with in vivo bioequivalence data from a study involving the product for which approval is being sought under the ANDA; Require ANDA 220582 and other ANDAs that reference BELBUCA to include data and information justifying the entire pH range in the product specifications to ensure that intentional changes to pH compared to BELBUCA. Nonrulemaking 2026-05-01T18:30:28Z 0b000064b92b9b4f

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