Details for New Drug Application (NDA): 070584

NDA 070584 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Somerset, Steriscience Speclts, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, and Intl Medicated, and is included in thirty-four NDAs. It is available from nineteen suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE 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 070584

Tradename:	BUPIVACAINE HYDROCHLORIDE
Applicant:	Hospira
Ingredient:	bupivacaine hydrochloride
Patents:	0

Pharmacology for NDA: 070584

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 070584

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070584	ANDA	Hospira, Inc.	0409-1162	0409-1162-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1162-18)
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070584	ANDA	Hospira, Inc.	0409-1162	0409-1162-02	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5%
Approval Date:	Feb 17, 1986	TE:	AP	RLD:	No

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