Details for New Drug Application (NDA): 203040

NDA 203040 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Eugia Pharma, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, and Intl Medication, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

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

Summary for 203040

Tradename:	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:	Eugia Pharma
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 203040

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 203040

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	203040	ANDA	Eugia US LLC	55150-158	55150-158-72	10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	203040	ANDA	Eugia US LLC	55150-159	55150-159-74	10 AMPULE in 1 CARTON (55150-159-74) / 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1%
Approval Date:	Mar 14, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2%
Approval Date:	Mar 14, 2013	TE:		RLD:	No

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