Requests that the FDA declare that the drug product, Flurbiprofen Tablets 25 mg is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5490

Requests that the FDA declare that the drug product, Flurbiprofen Tablets 25 mg is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 20, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Mar 30, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals Inc

declare that the drug product

Flurbiprofen Tablets 25 mg

is suitable for submission

in an Abbreviated New Drug Application

CLOSED

Data from Regulations.gov