Request that the FDA declare that the drug product, Tramadol Hydrochloride and Acetaminophen Tablet 300mg; 25mg is suitable for submission in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5984

Request that the FDA declare that the drug product, Tramadol Hydrochloride and Acetaminophen Tablet 300mg; 25mg is suitable for submission in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMay 27, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Senores Pharmaceuticals, Inc.	Jun 5, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals, Inc

declare that the drug product

Tramadol Hydrochloride

Acetaminophen Tablet 300mg

25mg is suitable for submission

Abbreviated New Drug Application

Data from Regulations.gov