ADVIL

FDA-2010-P-0145 · 8 docket documents

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-1996-P-0383 · 4 docket documents

Fuisz Technologies Ltd. filed this citizen petition requesting that the FDA extend the list of drug products suitable for abbreviated new drug applications to include ibuprofen in a Spoon Dose sachet formulation containing 200 mg, which offers improved swallowing and taste characteristics compared t

FDA-1987-P-0230 · 3 docket documents

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

FDA-1984-P-0033 · 22 docket documents

McNeil Consumer Products Company filed this citizen petition on March 21, 1984, pursuant to 21 C.F.R. § 10.30, opposing the FDA's proposed conditioning of over-the-counter approval for ibuprofen on the Agency's control of consumer advertising for the drug. McNeil requested that the Commissioner rule

FDA-2005-P-0130 · 10 docket documents

New York Medical College and colleagues filed this citizen petition on February 15, 2005, requesting that the FDA conduct a full risk assessment of Stevens-Johnson Syndrome and toxic epidermal necrolysis associated with ibuprofen products, investigate whether McNeil Pharmaceuticals and Wyeth Consume

FDA-2006-P-0395 · 7 docket documents

Strides Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for Ibuprofen Potassium 200 mg Phenylephrine Hydrochloride 10 mg Capsules, which substitutes phenylephrine hydrochloride