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XYLOCAINE VISCOUS

NDA

LIDOCAINE HYDROCHLORIDE | N009470 | FRESENIUS KABI USA LLC

1 strength0 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
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1:200,000 Injection in a 1.7 mL dental cartridge suitable for submission via Abbreviated New D	Other	2010-02-03	Withdrawn	—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.

Clinical Trials

500 trials from ClinicalTrials.gov — 5 recruiting, 2 active, 472 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Perioperative Lidocaine and Ketamine in Abdominal Surgery NCT04084548	Phase 3	Active	The Cleveland Clinic	420	2019-10-15 → 2025-12
Intralipid® 20% for Reversal of Local Anesthetics NCT03968822	Phase 4	Active	Hospital for Special Surgery, New York	18	2019-07-26 → 2026-10
Exparel Injection Effect on Postoperative Opioid Usage NCT04085913	Early Phase 1	By Invitation	University of Missouri-Columbia	100	2019-09-30 → 2025-07
Transforaminal Epidural Injection in Acute Sciatica NCT03924791	N/A	Recruiting	C.L.A.Vleggeert-Lankamp	142	2019-06-01 → 2026-07
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery NCT03756961	N/A	Recruiting	Göteborg University	220	2019-05-01 → 2029-12-31
Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.NCT03984656	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens	70	2019-06-04 → 2026-09-06
Lidocaine Infusion in Pancreatic Cancer NCT04048278	Early Phase 1	Recruiting	University of Illinois at Chicago	46	2018-11-08 → 2028-01-01
SPI-directed Analgesia for Vitreoretinal Surgeries NCT02973581	N/A	Completed	Medical University of Silesia	176	2016-02 → 2017-05
Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA NCT02920905	Phase 3	Completed	Assiut University	75	2015-11 → 2017-04
Intravenous Lidocaine and Ketorolac for Pain Management NCT02902770	Phase 4	Completed	Antonios Likourezos	150	2016-10 → 2019-09-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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
Sep 25, 2014	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.