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
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Rules, notices, and supporting material — the primary rule pinned first.
- Other· Aug 4, 2026No comment period
- Other· Aug 4, 2026No comment period