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Last Updated: March 26, 2023

Details for New Drug Application (NDA): 008816

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NDA 008816 describes XYLOCAINE, which is a drug marketed by Astrazeneca, Fresenius Kabi Usa, Akorn, and Dentsply Pharm, and is included in fourteen NDAs. It is available from seven suppliers. Additional details are available on the XYLOCAINE profile page.

The generic ingredient in XYLOCAINE is epinephrine; lidocaine hydrochloride. There are twenty-one 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 008816

Tradename:	XYLOCAINE
Applicant:	Akorn
Ingredient:	lidocaine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	JELLY;TOPICAL			Strength	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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