INJECTAPAP

FDA-2025-P-6262 · 3 docket documents

Americans for Scientific Integrity filed this citizen petition on November 17, 2025, requesting that FDA use the OTC monograph administrative order process under FDCA section 505G(b) to amend OTC Monograph M013 and revise Drug Facts labeling for all over-the-counter acetaminophen-containing products

FDA-2025-P-4513 · 9 docket documents

Parenteral Technologies LLC filed this citizen petition requesting the FDA to amend or remove the direction "if possible, use weight to dose" from over-the-counter single-ingredient acetaminophen liquid formulations for infants aged 2-3 years weighing 24-35 pounds, arguing the direction is misleadin

FDA-2025-P-4153 · 5 docket documents

Informed Consent Action Network, represented by Siri & Glimstad LLP, filed this citizen petition on September 22, 2025, requesting that the FDA require safety-related labeling changes for over-the-counter acetaminophen-containing drug products under OTC Monograph M013. The petitioner seeks to add wa

FDA-1985-P-0501 · 15 docket documents

Russ Pharmaceuticals, Inc. submitted a Section 505 citizen petition requesting that the FDA declare a drug product suitable for an abbreviated new drug application (ANDA). The product is a tablet containing 2.5 milligrams of hydrocodone bitartrate and 500 milligrams of acetaminophen indicated for re

FDA-2001-P-0298 · 4 docket documents

Pharmaceutical Associates, Inc. filed this citizen petition under section 505(j)(2)(c) requesting that the FDA declare an abbreviated new drug application (ANDA) suitable for a hydrocodone bitartrate and acetaminophen elixir containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL

FDA-2002-P-0341 · 8 docket documents

Lachman Consultants Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Oxycodone and Acetaminophen Tablets in a 2.5 mg / 300 mg

FDA-2024-P-2955 · 6 docket documents

Dsquare LLC filed a citizen petition under 21 CFR 10.30 requesting that the FDA require sodium-containing N-Acetylcysteine products marketed for acetaminophen intoxication treatment include warnings about high sodium content in patient information and a Black Box Warning for salt-sensitive individua

FDA-2023-P-4296 · 8 docket documents

FDA-2020-P-2296 · 26 docket documents

Parenteral Technologies LLC filed this citizen petition on November 21, 2020, requesting that the FDA amend the Tentative Final Monograph for over-the-counter single-ingredient acetaminophen children's dosages for ages 2 to under 4 years to include weight-based dosing methods, oral suspension dosage

FDA-2004-P-0345 · 4 docket documents

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 determine that an Abbreviated New Drug Application (ANDA) may be submitted for Acetaminophen, Butalbital and Caffeine Capsules USP at a strengt

FDA-2020-P-1071 · 6 docket documents

FDA-2019-P-5759 · 8 docket documents

Aavis Pharmaceuticals filed this petition on December 6, 2019, requesting that the FDA determine a new fixed-dose combination of Chlorzoxazone 250 mg and Acetaminophen 300 mg tablets is suitable for submission of an Abbreviated New Drug Application under section 505(j)(2)(C) of the Federal Food, Dru

FDA-2000-P-0580 · 4 docket documents

King & Spalding filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner declare that abbreviated new drug applications may be submitted for combination oxycodone hydrochloride/acetaminophen tablet products in four streng

FDA-1996-P-0441 · 7 docket documents

Mikart, Incorporated filed a suitability petition on June 14, 1996 requesting that the FDA amend the List of Drug Products Suitable for Abbreviated New Drug Applications to include Butalbital, Acetaminophen, and Caffeine Elixir (50 mg/325 mg/40 mg per 15 mL) in liquid form, arguing it is similar to

FDA-1996-P-0154 · 9 docket documents

Mikart, Incorporated filed this citizen petition under 21 U.S.C. 505(j)(2)(C) requesting that the FDA Commissioner determine whether Acetaminophen and Codeine Phosphate Tablets USP 325 mg/45 mg manufactured by KV Pharmaceuticals was discontinued from marketing for safety or effectiveness reasons, as

FDA-1999-P-3513 · 5 docket documents

King & Spalding filed this Section 505(j)(2)(C) citizen petition requesting that the FDA determine a liquid formulation containing 7.5 mg oxycodone hydrochloride and 500 mg acetaminophen per 15 mL is suitable for evaluation under an abbreviated new drug application (ANDA), based on the approved tabl

FDA-1999-P-4073 · 7 docket documents

Mikart, Incorporated filed a suitability petition requesting that the FDA amend the list of Drug Products Suitable for Abbreviated New Drug Applications to include Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50 mg/500 mg, a lower-strength variant of the reference listed drug DARVOCET-N

FDA-2017-P-4388 · 5 docket documents

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-1988-P-0040 · 5 docket documents

Biopharmaceutics, Inc. filed this citizen petition under 21 U.S.C. Section 505(j)(2)(A) and (C) requesting that the FDA find the combination drug Carisoprodol 200mg and Acetaminophen 325mg suitable for abbreviated new drug application approval, arguing that Acetaminophen can substitute for Aspirin i

FDA-1999-P-1857 · 7 docket documents

Mikart, Incorporated filed a suitability petition requesting that the FDA amend the List of Drug Products Suitable for Abbreviated New Drug Applications to include Butalbital, Acetaminophen, and Caffeine Tablets and Capsules in a 50 mg/500 mg/20 mg strength, which represents a modification of the pr

FDA-1999-P-0043 · 8 docket documents

Mikart, Incorporated filed a suitability petition on July 2, 1999, requesting that the FDA amend the list of Drug Products Suitable for Abbreviated New Drug Applications to include Propoxyphene Napsylate and Acetaminophen 100 mg/325 mg in tablet and capsule forms under 505(j)(2)(A) and (c), based on

FDA-1995-P-0100 · 4 docket documents

Mikart, Incorporated filed an ANDA Suitability Petition under 21 U.S.C. 505(j)(2)(A) and (C) requesting that the FDA amend Docket No. 82N 0032 to include Hydrocodone Bitartrate and Acetaminophen Capsules in 5 mg/325 mg strength as suitable for an abbreviated new drug application, citing the prior ap

FDA-2015-P-1153 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition under 21 CFR 10.30 and 314.161, requesting that the FDA determine whether Tylenol with Codeine Tablets (acetaminophen with codeine phosphate) in strengths of 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg were voluntarily withdrawn f

FDA-2014-P-1057 · 4 docket documents

Pharmacists Planning Service Inc filed a citizen petition requesting that FDA take action regarding the drug products propoxyphene and acetaminophen. The petition calls on FDA to remove propoxyphene-containing products from the market based on safety concerns, specifically requesting that the agency

FDA-2000-P-0565 · 3 docket documents

Pharmaceutical Associates, Inc. filed this citizen petition on November 28, 2000, requesting that the FDA declare that abbreviated new drug applications may be submitted for a higher-strength hydrocodone bitartrate and acetaminophen elixir containing 10 mg of hydrocodone bitartrate and 325 mg of ace

FDA-2013-P-0999 · 3 docket documents

The Consumer Healthcare Products Association filed this citizen petition on August 15, 2013, requesting that the FDA issue a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen over-the-counter drugs to include labeling with dosage information for ch

FDA-2012-P-0964 · 3 docket documents

Lannett Company, Inc. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that Abbreviated New Drug Applications may be submitted for hydrocodone bitartrate and acetaminophen tablets in strengths of 2.5 mg

FDA-2012-P-0775 · 3 docket documents

Xspire Pharma, LLC filed this ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Tablets at a reduced strength of 312.5 mg/60 mg/32 mg instead of the current 712.8 mg/60 mg/32 mg mar

FDA-2012-P-0478 · 3 docket documents

Xspire Pharma, LLC filed this ANDA Suitability Petition under 21 CFR 314.93 on May 7, 2012, requesting permission to submit an Abbreviated New Drug Application for Acetaminophen and Pentazocine Hydrochloride Tablets reformulated to a strength of 312.5 mg acetaminophen and 25 mg pentazocine hydrochlo

FDA-2011-P-0728 · 3 docket documents

WraSer Pharmaceuticals, LLC submitted an ANDA Suitability Petition on October 5, 2011 under 21 CFR 314.93 requesting permission to file an abbreviated new drug application for a reformulated version of Trezix (Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Capsules) with reduced acetaminophen st

FDA-2011-P-0459 · 3 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Pentazocine Hydrochloride and Acetaminophen Tablets in 12.5 mg/325 mg and 25 mg/325 mg strengths suitable for submission as an ANDA, with Watson Pharma's 25 mg/650 mg product (ANDA 74-

FDA-2011-P-0302 · 4 docket documents

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-1977-N-0013 · 35 docket documents

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

FDA-2011-P-0106 · 7 docket documents

Lachman Consultant Services, Inc., filing on behalf of a client, submitted this 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 appl

FDA-2010-P-0011 · 8 docket documents

Bright Future Pharmaceuticals Factory, a Hong Kong-based manufacturer, filed a suitability petition under Section 505(b)(2)(C) requesting permission to submit an Abbreviated New Drug Application for BF-PARADAC, a 500 mg acetaminophen oral immediate-release tablet, and sought FDA designation of Panad

FDA-2002-P-0443 · 6 docket documents

Frommer Lawrence & Haug LLP filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA authorization to submit an abbreviated new drug application (ANDA) for propoxyphene napsylate and acetaminophen oral tablets in strengths of 100 mg/325

FDA-1997-P-0176 · 4 docket documents

Stanford University School of Medicine's Departments of Genetics and Medicine, led by Leonore A. Herzenberg and John James of AIDS Treatment News, filed this citizen petition requesting that the FDA investigate whether acetaminophen and other glutathione-depleting drugs should carry warning labels f

FDA-2009-P-0429 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition under Section 505(b)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride and Acetaminophen Tablets, 75 mg/650 mg suitable for consideration in an abbreviated new drug application (ANDA), based o

FDA-2009-P-0203 · 5 docket documents

Lachman Consultant Services, Inc., filed this citizen petition on behalf of an unnamed client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/500 mg, 5 m

FDA-2006-P-0278 · 19 docket documents

The law firm Kleinfeld, Kaplan and Becker submitted this citizen petition under Section 505(j)(2)(C) on behalf of a client requesting that FDA declare Hydrocodone Bitartrate and Acetaminophen Orally Disintegrating Tablets at 5 mg/500 mg suitable for submission as an ANDA, with the only change from t

FDA-2006-P-0324 · 5 docket documents

Pharmacists Planning Service, Inc. and physicians from California Pacific Medical Center and University of California San Francisco submitted this petition under 21 CFR 10.20 and 10.30 requesting that the FDA mandate clear labeling on all non-aspirin acetaminophen-containing over-the-counter product

FDA-2006-P-0280 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Propoxyphene Napsylate 100 mg and Acetaminophen 400 mg Tablet suitable for submission as an ANDA, seeking approval for a reduced acetaminophen strength compared to the reference-listed drug Da

FDA-2006-P-0145 · 9 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on December 12, 2006, pursuant to Section 505(q)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare a Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg tablet suitable for submission as an ANDA, with

FDA-2006-P-0456 · 8 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Propoxyphene Napsylate 100 mg with Acetaminophen 300 mg Tablets and Propoxyphene Napsylate 50 mg with Acetaminophe

FDA-2007-P-0242 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Acetaminophen 400 mg, Butalbital 50 mg, and Caffeine 40 mg Capsules suitable for submission as an abbreviated new drug ap

FDA-1990-P-0454

The Food and Drug Administration is withdrawing approval of 128 suitability petitions that had been granted prior to the enactment of the Pediatric Research Equity Act of 2003 because no abbreviated new drug applications were ever submitted for these drugs, and any such applications submitted after