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 | Federal Regulations · Congress.wiki

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FDA

FDA-2023-P-4617

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

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 20, 2023

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Nostrum Laboratories, Inc.	Jan 17, 2024	--

Keywords

CDER

Suitability Petition

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

Data from Regulations.gov