Details for New Drug Application (NDA): 006488

NDA 006488 describes XYLOCAINE W/ EPINEPHRINE, which is a drug marketed by Astrazeneca and Fresenius Kabi Usa and is included in two NDAs. It is available from eight suppliers. Additional details are available on the XYLOCAINE W/ EPINEPHRINE profile page.

The generic ingredient in XYLOCAINE W/ EPINEPHRINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 006488

Tradename:	XYLOCAINE W/ EPINEPHRINE
Applicant:	Fresenius Kabi Usa
Ingredient:	epinephrine; lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 006488

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 006488

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XYLOCAINE	lidocaine hydrochloride	INJECTABLE;INJECTION	006488	NDA	Henry Schein, Inc.	0404-9972	0404-9972-20	1 VIAL in 1 BAG (0404-9972-20) / 20 mL in 1 VIAL
XYLOCAINE	lidocaine hydrochloride	INJECTABLE;INJECTION	006488	NDA	Henry Schein, Inc.	0404-9973	0404-9973-20	1 VIAL in 1 BAG (0404-9973-20) / 20 mL in 1 VIAL

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.01MG/ML;2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.01MG/ML;1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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