Request that the FDA declare that the drug product, Fingolimod Oral Solution, 0.5 mg/5 mL and 15 mg/150 mL is suitable for submission in an Abbreviated New Drug Application (ANDA)
🏛 Food and Drug Administration (FDA)FDA-2026-P-6537
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
- Other· Jun 25, 2026No comment period
- Supporting & Related Material· Jun 25, 2026
- Supporting & Related Material· Jun 25, 2026
- Other· Jun 8, 2026No comment period