DURLAZA

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-2014-P-2169 · 6 docket documents

Lachman Consultant Services Inc filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Aspirin 300 mg, Butalbital 50 mg and Caffeine 40 mg Capsules suitable for submission as an ANDA, with the reference listed drug being Fiorinal Cap

FDA-2014-P-2168 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Aspirin 300 mg, Butalbital 50 mg, Caffeine 40 mg, and Codeine Phosphate 30 mg Capsules suitable for submission as an ANDA, with Fiorinal with Co

FDA-1977-N-0018 · 89 docket documents

Bayer Healthcare LLC filed this citizen petition on February 11, 2003, under 21 CFR 330.10 requesting that the FDA amend the Final Rule for Professional Labeling for Aspirin to include use of 75mg-325mg aspirin for primary prevention of myocardial infarction in individuals at sufficient risk, suppor

FDA-2012-P-1267 · 3 docket documents

Xspire Pharma, LLC filed an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Aspradone (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/5 mg) with a different strength than the reference listed drug ANDA A089-420 for Azdone (Aspiri

FDA-2011-P-0460 · 4 docket documents

Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Talwin Compound (aspirin and pentazocine hydrochloride) Tablets, 325 mg/12.5 mg, NDA 16-891 by Sanofi Aventis, was voluntarily withdrawn from marketing for safety or effectiveness reasons under 21 CFR 314

FDA-1992-P-0118 · 11 docket documents

Stanley E. Cohen filed a citizen petition in January 1992 requesting that the FDA conduct a survey to determine the extent of adverse reactions from aspirin maintenance therapy in elderly populations and revise the analgesics monograph to authorize lower aspirin dosages appropriate for daily use. Co

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