Last Updated: August 11, 2026

Details for New Drug Application (NDA): 202346

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NDA 202346 describes LIDOCAINE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Chartwell Rx, Cosette Pharms Nc, Encube, Fougera Pharms Inc, Geneyork Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Sun Pharma Canada, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Difgen Pharms, Ibsa, Nal Pharm, Noven Pharms Inc, Pharmobedient, Uspharma, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Zydus Lifesciences, Abbott, Abraxis Pharm, Afaxys, Am Regent, Anthea Pharma, Aspiro, B Braun Medical, Bel Mar, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Spectra Mdcl Devices, Viwit Pharm, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Yiling, Sentiss, Watson Labs Inc, Rubicon Research, Lannett Co Inc, Novitium Pharma, Paco, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and fifty NDAs. It is available from forty-two suppliers. Additional details are available on the LIDOCAINE profile page.

The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 202346

Tradename:	LIDOCAINE
Applicant:	Pharmobedient
Ingredient:	lidocaine
Patents:	0

Medical Subject Heading (MeSH) Categories for 202346

Anesthetics, Local
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	PATCH;TOPICAL			Strength	5%
Approval Date:	Aug 7, 2015	TE:	AB	RLD:	No

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