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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 219535

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NDA 219535 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Neocubes Pharma, Rising, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Yiling, Cosette, Sentiss, Watson Labs Inc, Aurobindo Pharma Ltd, Hikma, Pharmobedient, Rubicon Research, Lannett Co Inc, Novitium Pharma, Paco, Pai Holdings Pharm, Sun Pharma Canada, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Extrovis, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and eleven NDAs. It is available from forty-nine suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

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

Summary for 219535

Tradename:	LIDOCAINE HYDROCHLORIDE
Applicant:	Neocubes Pharma
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 219535

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 219535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	219535	ANDA	Avenacy, LLC	83634-651	83634-651-50	25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-50) / 50 mL in 1 VIAL, MULTI-DOSE (83634-651-43)
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	219535	ANDA	Anthea Pharma Private Limited	83854-009	83854-009-25	25 VIAL in 1 TRAY (83854-009-25) / 50 mL in 1 VIAL (83854-009-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1%
Approval Date:	Apr 2, 2025	TE:	AP	RLD:	No

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