ATROPINE SULFATE

FDA-2023-P-4550 · 8 docket documents

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 · 4 docket documents

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 · 5 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 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 · 5 docket documents

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