Details for New Drug Application (NDA): 217792

NDA 217792 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 eighteen 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 217792

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

Pharmacology for NDA: 217792

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 217792

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	217792	ANDA	Somerset Therapeutics, LLC	70069-752	70069-752-01	1 VIAL in 1 CARTON (70069-752-01) / 50 mL in 1 VIAL
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	217792	ANDA	Somerset Therapeutics, LLC	70069-752	70069-752-10	10 VIAL in 1 CARTON (70069-752-10) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25%
Approval Date:	Nov 20, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5%
Approval Date:	Nov 20, 2023	TE:	AP	RLD:	No

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