Requests that the FDA declare that Semaglutide Injection, 1mg/1.5 mL (0.68 mg/mL), 2mg/1.5 mL (1.34 mg/mL), 4mg/3 mL (1.34 mg/mL), 6.8mg/3 mL (2.27 mg/mL), 9.6mg/3 mL (3.2 mg/mL) in pre-filled, disposable and multi-dose pen injector, is suitable for submission as an ANDA
🏛 Food and Drug Administration (FDA)FDA-2025-P-7376
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Rules, notices, and supporting material — the primary rule pinned first.
- Other· Jul 16, 2026No comment period
- Other· Dec 29, 2025No comment period
