XYLOCAINE

FDA-2019-P-0417 · 11 docket documents

Scilex Pharmaceuticals Inc filed this citizen petition on December 28, 2018, requesting that the FDA remove from the market unapproved lidocaine-containing drug products in patch, plaster, poultice, and comparable delivery systems that lack approved NDAs or ANDAs under 21 U.S.C. § 355, and requestin

FDA-2017-P-2528 · 15 docket documents

Apotex Inc filed this citizen petition requesting that the FDA withdraw approval of the NDA for Lidoderm (lidocaine patch 5%) and deny any applications for lidocaine patches with similar formulations due to patent issues and concerns regarding the appropriateness of the original approval decision.

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requesting that the FDA determine AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn from marketing for reasons other than safety or efficacy, thereby permitting submission and app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

FDA-2006-P-0346 · 15 docket documents

Endo Pharmaceuticals Inc. filed this citizen petition on December 18, 2006, requesting that the FDA apply comparative clinical efficacy trial requirements under 21 C.F.R. § 320.24(b)(4) to any abbreviated new drug application seeking approval of a generic version of Lidoderm (lidocaine topical patch

FDA-2008-P-0214 · 4 docket documents

Odan Laboratories Ltd. filed this citizen petition under Section 505 and 21 CFR 314.55(d)(2), 314.93, and 10.30 requesting that the FDA determine a non-aerosol oral spray delivering 10 mg lidocaine per metered dose is suitable for filing as an ANDA, with the reference product being the discontinued