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Oral Solution, 10mg/mL; under New Drug Application (NDA) N020657 held by JANSSEN PHARMACEUTICALS INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons.
🏛 Food and Drug Administration (FDA)FDA-2026-P-4021
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
- Supporting & Related Material· Jun 15, 2026