Details for New Drug Application (NDA): 091503

NDA 091503 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 091503

Tradename:	BUPIVACAINE HYDROCHLORIDE
Applicant:	Steriscience Speclts
Ingredient:	bupivacaine hydrochloride
Patents:	0

Pharmacology for NDA: 091503

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 091503

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091503	ANDA	Xellia Pharmaceuticals USA LLC	70594-116	70594-116-01	50 mL in 1 VIAL, MULTI-DOSE (70594-116-01)
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091503	ANDA	Xellia Pharmaceuticals USA LLC	70594-119	70594-119-01	50 mL in 1 VIAL, MULTI-DOSE (70594-119-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25%
Approval Date:	Oct 18, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5%
Approval Date:	Oct 18, 2011	TE:	AP	RLD:	No

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