LIDOCAINE HYDROCHLORIDE | N006488 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Foley & Lardner, LLP FDA-2020-P-1252 · 7 docket documents Foley & Lardner LLP filed an ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine a 2 mL fill vial formulation of Lidocaine Hydrochloride Injection USP 10 mg/mL is suitable for ANDA submission, with the formulation being quant | Suitability | 2020-04-07 | Withdrawn | Foley & Lardner, LLP |
Citizen Petition from Arent Fox, P.L.L.C. 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requesting that the FDA determine AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn from marketing for reasons other than safety or efficacy, thereby permitting submission and app | Other | 2013-01-24 | Withdrawn | Arent Fox, P.L.L.C. |
Arent Fox, LLP - Citizen Petition 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1:200,000 Injection in a 1.7 mL dental cartridge suitable for submission via Abbreviated New D | Other | 2010-02-03 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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