ATROPINE

FDA-2026-P-1534

Dr. Robert Gold, MD and Dr. Cheryl Chapman, OD filed this citizen petition pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act and 21 CFR §10.30 requesting that the FDA reconsider and expedite regulatory review of SYD-101, a standardized low-dose atropine ophthalmic formulation for p

FDA-2023-P-4550

Pharmobedient Consulting LLC filed a suitability petition requesting that the FDA evaluate the prescribing information for atropine to determine its appropriateness and suitability for its intended use. The petition seeks FDA review of the product's labeling under regulatory mechanisms governing dru

FDA-2023-P-4550

Pharmobedient Consulting LLC filed a suitability petition regarding atropine prescribing information. The petition requests FDA guidance on the suitability of proposed labeling for an atropine product, as indicated by the draft prescribing information included as an attachment.

FDA-2023-P-4550

Pharmobedient Consulting LLC filed a petition regarding atropine sulfate seeking FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations. The petition requests clarification on regulatory pathways and acceptance criteria for atropine sulfate submissions under app

FDA-2014-P-2142

Zydus Pharmaceuticals (USA) Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Atropine Sulfate Injection USP, 0.4 mg/mL in a 20 mL multidose vial suitable for submission as an abbreviated new drug application (AND

FDA-2014-P-1670

Gordon Johnston Regulatory Consultants LLC filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Atropine Sulfate Injection USP, 0.4 mg/ml, 20 ml multiple-dose vial suitable for submission in an abbreviated new drug application (ANDA), with the reference-listed drug

FDA-2005-P-0134

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 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP at a strength of 5 mg/0.05 mg per 5 mL suitable for sub

FDA-2005-P-0381

Lachman Consultant Services, Inc. filed this petition on April 25, 2005, requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP 5 mg/0.05 mg suitable for submission as an ANDA based on the reference listed drug Lomotil Tablets 2.5 mg/0.025 mg. The petition seeks