Last Updated: April 30, 2026

Details for New Drug Application (NDA): 206463

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NDA 206463 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-nine 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. Thirteen suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 206463

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

Pharmacology for NDA: 206463

Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for 206463

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

Suppliers and Packaging for NDA: 206463

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE	lidocaine	PATCH;TOPICAL	206463	ANDA	AvKARE	42291-477	42291-477-30	30 POUCH in 1 BOX (42291-477-30) / 1 PATCH in 1 POUCH (42291-477-11)
LIDOCAINE	lidocaine	PATCH;TOPICAL	206463	ANDA	A-S Medication Solutions	50090-7894	50090-7894-2	30 POUCH in 1 CARTON (50090-7894-2) / 1 PATCH in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	PATCH;TOPICAL			Strength	5%
Approval Date:	Aug 24, 2020	TE:	AB	RLD:	No

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