Requests that the FDA find the proposed drug product Phenylephrine Hydrochloride Injection, 1 mg/10 mL (0.1 mg/mL) in a pre-filled syringe is suitable for submission as an Abbreviated New Drug Application.
🏛 Food and Drug Administration (FDA)FDA-2026-P-6257
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📄 Primary document
- Other· Jun 18, 2026No comment period
- Other· Jun 2, 2026No comment period