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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 205318

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NDA 205318 describes LIDOCAINE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Cosette, Dr Reddys, Encube, Fougera Pharms Inc, Geneyork Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Taro, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Ibsa, Mylan Technologies, Nal Pharm, Noven Pharms Inc, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Rhodes Pharms, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, 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, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sentiss, Watson Labs Inc, Rubicon, Wockhardt Bio Ag, 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 forty-two 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. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 205318

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

Pharmacology for NDA: 205318

Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for 205318

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

Suppliers and Packaging for NDA: 205318

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE	lidocaine	OINTMENT;TOPICAL	205318	ANDA	DIRECTRX	61919-774	61919-774-35	35.44 g in 1 TUBE (61919-774-35)
LIDOCAINE	lidocaine	OINTMENT;TOPICAL	205318	ANDA	DIRECTRX	61919-774	61919-774-50	50 g in 1 CARTON (61919-774-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	5%
Approval Date:	Feb 1, 2016	TE:		RLD:	No

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