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XYLOCAINE 4% PRESERVATIVE FREE

NDA

LIDOCAINE HYDROCHLORIDE | N010417 | FRESENIUS KABI USA LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lyne Laboratories, Inc FDA-2021-P-1248 Lyne Laboratories, Inc. filed this petition requesting that the FDA determine whether Xylocaine (lidocaine hydrochloride) 4% Topical Solution, originally approved under NDA 010417 and currently held by Fresenius Kabi USA LLC, was voluntarily withdrawn from sale for safety or effectiveness reasons pu	Other	2021-12-07	Denied	Lyne Laboratories

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs4 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

MOEHS IBERICA SLLIDOCAINE HYDROCHLORIDE

DMF 58761985

DELTA SYNTHETIC CO LTDLIDOCAINE HYDROCHLORIDE

DMF 113381995

CAMBREX KARLSKOGA ABLIDOCAINE HYDROCHLORIDE

DMF 195312006

MAHENDRA CHEMICALSLIDOCAINE HYDROCHLORIDE USP

DMF 240512010

SWATI SPENTOSE PRIVATE LTDLIDOCAINE HYDROCHLORIDE USP

DMF 259632012

APEX HEALTHCARE LTDLIDOCAINE HYDROCHLORIDE USP

DMF 391392023

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDLIDOCAINE HYDROCHLORIDE

DMF 408142024

HOECHST AGInactiveLIDOCAINE HYDROCHLORIDE AND BASE(BULK

DMF 59211985

GUFIC BIOSCIENCES LTDInactiveLIDOCAINE HYDROCHLORIDE

DMF 174832004

KONDUSKAR LABORATORIES PVT LTDInactiveLIDOCAINE HYDROCHLORIDE USP

DMF 240562010

APEX HEALTHCARE LTDInactiveLIDOCAINE HYDROCHLORIDE USP

DMF 343072020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 25, 2010	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4%

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;TOPICAL | Approved: Approved Prior to Jan 1, 1982