Requests that the FDA declare that Oxycodone Hydrochloride and Acetaminophen Oral Solution, in strengths of 2.5 mg/325 mg per 5 mL, 7.5 mg/325 mg per 5 mL and 10 mg/325 mg per 5 mL strengths, are suitable for review under an Abbreviated New Drug Application (ANDA) supplement (PAS), pursuant to section 505(j) of the Federal Food, Drug and Cosmetic Act, as amended.; CLOSED
🏛 Food and Drug Administration (FDA)FDA-2023-P-4617
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