Details for New Drug Application (NDA): 018304

NDA 018304 describes SENSORCAINE, which is a drug marketed by Fresenius Kabi Usa and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SENSORCAINE profile page.

The generic ingredient in SENSORCAINE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.

Summary for 018304

Tradename:	SENSORCAINE
Applicant:	Fresenius Kabi Usa
Ingredient:	bupivacaine hydrochloride; epinephrine bitartrate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018304

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

Suppliers and Packaging for NDA: 018304

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018304	NDA	Henry Schein, Inc.	0404-9945	0404-9945-50	1 VIAL in 1 BAG (0404-9945-50) / 50 mL in 1 VIAL
SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018304	NDA	Henry Schein, Inc.	0404-9947	0404-9947-50	1 VIAL, MULTI-DOSE in 1 BAG (0404-9947-50) / 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.75%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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