Details for New Drug Application (NDA): 071168

NDA 071168 describes BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by Hospira and is included in eight NDAs. It is available from two suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.

Summary for 071168

Tradename:	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Applicant:	Hospira
Ingredient:	bupivacaine hydrochloride; epinephrine
Patents:	0

Pharmacology for NDA: 071168

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

Suppliers and Packaging for NDA: 071168

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071168	ANDA	Hospira, Inc.	0409-9045	0409-9045-01	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9045-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9045-11)
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071168	ANDA	Hospira, Inc.	0409-9045	0409-9045-17	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9045-17) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9045-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5%;0.005MG/ML
Approval Date:	Jun 16, 1988	TE:	AP	RLD:	No

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