INJECTAPAP

FDA-2023-P-4296

Lachman Consultant Services, Inc. filed a suitability petition regarding proposed prescribing information for acetaminophen injection in two formulations: 500 mg/50 mL and 650 mg/65 mL. The petition seeks FDA evaluation of the suitability of the proposed labeling for these injectable acetaminophen p

FDA-2023-P-4296

Lachman Consultant Services, Inc. filed a citizen petition regarding OFIRMEV (acetaminophen) injection, requesting FDA review of the suitability of the prescribing information based on updated safety and clinical data available as of February 2020.

FDA-2023-P-4296

I cannot provide a summary of this FDA citizen petition because the document provided contains only a title and reference line without substantive content describing who filed the petition, what specific action was requested, or the detailed basis for the petition. To accurately summarize the petiti

FDA-2020-P-1071

Hyman, Phelps & McNamara, PC filed a suitability petition regarding acetaminophen injection, proposing prescribing information for the product. The document appears to be an attachment supporting the petitioner's request for FDA consideration of the proposed labeling for this intravenous pain manage

FDA-2017-P-4388

Abhai, LLC filed a suitability petition regarding butalbital, acetaminophen, and caffeine tablets manufactured by Par Pharmaceutical, requesting FDA determination of suitability for abbreviated new drug application (ANDA) filing or related regulatory pathway consideration for this combination produc

FDA-2011-P-0302

Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325

FDA-2011-P-0167

Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Butalbital and Acetaminophen Capsules 50 mg/300 mg suitable for submission as an abbreviated new drug applicati

FDA-1977-N-0013

GlaxoSmithKline Consumer Healthcare filed this citizen petition on March 14, 2011, requesting that the FDA maintain the current over-the-counter availability of acetaminophen at a 1,000 mg single adult dose under the Tentative Final Monograph for Internal Analgesic, Antipyretic and Antirheumatic Dru