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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.
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Suitability Petition from Apotex Corp.
Suitability Petition from Apotex Corp.
Nonrulemaking
Other
FDA-2026-P-6257-0001
Pharmaceutical Policy
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The document's own metadata, straight from regulations.gov.
Posted
Jun 2, 2026
Agency
Food and Drug Administration (FDA)
