MOTRIN

FDA-2026-P-3631

Hyman, Phelps & McNamara, P.C. filed this suitability petition on behalf of a client requesting that the FDA declare Ibuprofen Tablets, 1,200 mg, suitable for submission as an ANDA under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, with the RLD being MOTRIN (ibuprofen) Tablets a

FDA-2026-P-2355

Premier Research International LLC filed this ANDA Suitability Petition under section 505(j)(2)(C) requesting FDA confirmation that ibuprofen tablets in 500 mg and 700 mg strengths are suitable for submission as an Abbreviated New Drug Application, with the reference listed drug being Motrin ibuprof

FDA-2010-P-0145

Actavis Mid-Atlantic LLC filed this citizen petition on March 12, 2010, requesting that the FDA determine that a new dosage form of ibuprofen—Adult Ibuprofen Oral Suspension, 100 mg/5 mL—is suitable for submission as an ANDA using McNeil's Motrin IB Tablets, 200 mg as the reference listed drug under

FDA-1987-P-0230

Sidmak Laboratories, Inc. filed this citizen petition under section 505(j)(2)(c) of the Food Drug and Cosmetic Act on July 6, 1987, requesting that the FDA approve the filing of an abbreviated new drug application (ANDA) for ibuprofen 200mg in soft gelatin capsule form, which would be bioequivalent