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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 208822

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NDA 208822 describes LIDOCAINE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Chartwell Rx, Cosette, 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, 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, Extrovis, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and forty-eight NDAs. It is available from thirty-eight 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. Fourteen suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 208822

Tradename:	LIDOCAINE
Applicant:	Vitruvias Therap
Ingredient:	lidocaine
Patents:	0

Medical Subject Heading (MeSH) Categories for 208822

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	5%
Approval Date:	Sep 25, 2017	TE:		RLD:	No

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