Request that the FDA declare that Ibuprofen Tablets, 1,200 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-3631

Request that the FDA declare that Ibuprofen Tablets, 1,200 mg, is suitable for submission as an ANDA

Documents

Comments

Description

OPEN

Comment Period OpensApr 2, 2026

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Hyman, Phelps & McNamara, P.C.	Apr 20, 2026	--

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

declare that Ibuprofen Tablets, 1,200 mg,

is suitable for submission as an ANDA

Approved Drug Products with

Therapeutic Equivalence Evaluations

Orange Book