ATROPINE SULFATE

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-2023-P-4550

Pharmobedient Consulting, LLC submitted this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Atropine Sulfate Ophthalmic Ointment, 1% suitable for submission in an ANDA, changing the dosage form from the reference listed dru

FDA-2014-P-2243

Apotex Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Atropine Sulfate Ophthalmic Solution, USP, 1%, subject of NDA #206289 held by Akom, as a reference listed drug in the Orange Book to enable Apotex to submit an AN

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