Details for New Drug Application (NDA): 214348

NDA 214348 describes BUPIVACAINE LIPOSOME, which is a drug marketed by Hengrui Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the BUPIVACAINE LIPOSOME profile page.

The generic ingredient in BUPIVACAINE LIPOSOME is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.

Summary for 214348

Tradename:	BUPIVACAINE LIPOSOME
Applicant:	Hengrui Pharma
Ingredient:	bupivacaine
Patents:	0

Pharmacology for NDA: 214348

Physiological Effect

Local Anesthesia

Medical Subject Heading (MeSH) Categories for 214348

Anesthetics, Local

Suppliers and Packaging for NDA: 214348

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPIVACAINE LIPOSOME	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	214348	ANDA	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	57884-3251	57884-3251-1	10 VIAL in 1 CARTON (57884-3251-1) / 10 mL in 1 VIAL
BUPIVACAINE LIPOSOME	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	214348	ANDA	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	57884-3252	57884-3252-1	10 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	133MG/10ML (13.3MG/ML)
Approval Date:	Jul 1, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	266MG/20ML (13.3MG/ML)
Approval Date:	Jul 1, 2024	TE:	AP	RLD:	No

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