Details for New Drug Application (NDA): 212822

NDA 212822 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Onesource Specialty, Somerset, B Braun Medical, Baxter Hlthcare Corp, Huons, and Intl Medicated, and is included in thirty-four NDAs. It is available from twenty-one 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 212822

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

Pharmacology for NDA: 212822

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 212822

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	212822	ANDA	Brookfield Pharmaceuticals, LLC.	71351-022	71351-022-10	10 AMPULE in 1 PACKAGE (71351-022-10) / 2 mL in 1 AMPULE (71351-022-02)
BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	212822	ANDA	Brookfield Pharmaceuticals, LLC.	71351-022	71351-022-50	50 AMPULE in 1 PACKAGE (71351-022-50) / 2 mL in 1 AMPULE (71351-022-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SPINAL			Strength	0.75%
Approval Date:	Dec 30, 2019	TE:	AP	RLD:	No

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