XYLOCAINE

FDA-2022-P-1965 · 4 docket documents

Law firm Hahn Loeser & Parks LLP filed this petition requesting that the FDA Commissioner determine whether Akorn Operating Co. LLC's Xylocaine (Lidocaine Hydrochloride) Jelly 2%, approved under NDA 008816, was voluntarily withdrawn from the market for safety or effectiveness reasons. The petitioner

FDA-2020-P-2013 · 3 docket documents

Lachman Consulting Services, Inc. filed this citizen petition requesting that FDA amend the Orange Book to designate Lidocaine Hydrochloride Topical Jelly, 2% approved under ANDA 040433 as a new Reference Standard, arguing that the current Reference Standard and Reference Listed Drug (XYLOCAINE Topi

FDA-2020-P-1914 · 3 docket documents

Aurolife Pharma LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Lidocaine Hydrochloride Jelly 2% (ANDA 040433) manufactured by Akorn Inc. as a new reference standard for developing generic versions, because the curren

FDA-2004-P-0176 · 6 docket documents

Arent Fox PLLC filed this citizen petition on behalf of an unnamed petitioner requesting that the FDA determine AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn from marketing for reasons other than safety or efficacy, thereby permitting submission and app

FDA-2010-P-0072 · 7 docket documents

Arent Fox, LLP filed this suitability petition under Section 505(j)(2)(C) of the Food, Drug, and Cosmetic Act requesting that the FDA declare a new dosage form of Lidocaine Hydrochloride 2% and Epinephrine 1:200,000 Injection in a 1.7 mL dental cartridge suitable for submission via Abbreviated New D