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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086283

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NDA 086283 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Luitpold Pharms Inc, Lyphomed, Miles, Mylan Labs Ltd, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, G And W Labs Inc, Watson Labs Inc, Hi Tech Pharma, Wockhardt Bio Ag, Paco, Teligent Pharma Inc, Vintage, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in ninety-four NDAs. It is available from twenty-nine suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

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

Summary for 086283

Tradename:	LIDOCAINE HYDROCHLORIDE
Applicant:	Intl Medication
Ingredient:	lidocaine hydrochloride
Patents:	0
Therapeutic Class:	Anesthetics
Formulation / Manufacturing:	see details

Pharmacology for NDA: 086283

Ingredient-type	Amides
Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 086283

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	JELLY;TOPICAL	086283	ANDA	General Injectables & Vaccines, Inc	52584-030	N	52584-030-05
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	JELLY;TOPICAL	086283	ANDA	General Injectables & Vaccines, Inc	52584-034	N	52584-034-05

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	JELLY;TOPICAL			Strength	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	No

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Serving hundreds of leading biopharmaceutical companies globally:

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