Last Updated: November 8, 2026

Details for New Drug Application (NDA): 219535

« Back to Dashboard

NDA 219535 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Adaptis, 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, Heritage, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Pharmobedient, Rising, Spectra Mdcl Devices, Viwit Pharm, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Cosette Pharms Nc, Sentiss, Watson Labs Inc, Aurobindo Pharma Ltd, Hikma, Quagen, Rubicon Research, Lannett Co Inc, Novitium Pharma, Paco, Pai Holdings Pharm, Sun Pharma Canada, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Chartwell Rx, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and thirteen NDAs. It is available from forty-seven suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are two 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 219535

Tradename:	LIDOCAINE HYDROCHLORIDE
Applicant:	Adaptis
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	Sandoz Inc.	0781-3537	0781-3537-25	25 VIAL in 1 CARTON (0781-3537-25) / 30 mL in 1 VIAL (0781-3537-90)
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	219535	ANDA	Sandoz Inc.	0781-3537	0781-3537-35	25 VIAL in 1 CARTON (0781-3537-35) / 5 mL in 1 VIAL (0781-3537-75)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2%
Approval Date:	Feb 6, 2026	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.