documents: FDA-2025-N-5935-0001

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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id agency_id docket_id title document_type subtype posted_date posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2025-N-5935-0001 FDA FDA-2025-N-5935 Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams Notice Withdrawal 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z   2025-11-24T18:52:14Z 2025-20767 0 0 09000064b90936f4

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