Details for New Drug Application (NDA): 016801

NDA 016801 describes XYLOCAINE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. Additional details are available on the XYLOCAINE PRESERVATIVE FREE profile page.

The generic ingredient in XYLOCAINE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

Summary for 016801

Tradename:	XYLOCAINE PRESERVATIVE FREE
Applicant:	Fresenius Kabi Usa
Ingredient:	lidocaine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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:	No

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