Details for New Drug Application (NDA): 009435

NDA 009435 describes NESACAINE-MPF, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from three suppliers. Additional details are available on the NESACAINE-MPF profile page.

The generic ingredient in NESACAINE-MPF is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.

Summary for 009435

Tradename:	NESACAINE-MPF
Applicant:	Fresenius Kabi Usa
Ingredient:	chloroprocaine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 009435

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 009435

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435	NDA	Henry Schein, Inc.	0404-9926	0404-9926-30	1 VIAL in 1 BAG (0404-9926-30) / 30 mL in 1 VIAL
NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435	NDA	Henry Schein, Inc.	0404-9927	0404-9927-30	1 VIAL, MULTI-DOSE in 1 BAG (0404-9927-30) / 30 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

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

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	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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