dockets: FDA-2026-P-4021

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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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id agency_id title docket_type last_modified object_id
FDA-2026-P-4021 FDA Requests that the FDA determine whether the Reference Listed Drug (RLD) SPORANOX (ITRACONAZOLE) Oral Solution, 10mg/mL; under New Drug Application (NDA) N020657 held by JANSSEN PHARMACEUTICALS INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons. Nonrulemaking 2026-06-15T18:19:33Z 0b000064b927a186

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