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Nonrulemaking

Requests that the FDA determine that NDA 212642 (Gallium Ga 68 Gozetotide Injection, 0.5–5 mCi/mL) is pharmaceutically equivalent, as defined in 21 CFR 314.3, to NDA 212643 (Gallium Ga 68 Gozetotide Injection, 0.5–5 mCi/mL

🏛 Food and Drug Administration (FDA)FDA-2026-P-8558
Pharmaceutical Policy
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Rules, notices, and supporting material — the primary rule pinned first.

All 5Supporting & Related Material 3Other 2
📄 Primary document
OtherAug 4, 2026
Citizen Petition from University of California, Los Angeles (UCLA)
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