Requests that the FDA determine that the proposed Ibuprofen Tablets (500 mg and 700 mg) are suitable for submission as an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2355

Requests that the FDA determine that the proposed Ibuprofen Tablets (500 mg and 700 mg) are suitable for submission as an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 6, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Mar 23, 2026	--

Keywords

CDER

Suitability Petition

Premier Research International LLC

Requests that the FDA determine that the

proposed Ibuprofen Tablets (500 mg and 700 mg)

are suitable for submission as an

Abbreviated New Drug Application (ANDA)

The RLD upon which the petition is based is:

Data from Regulations.gov