Details for New Drug Application (NDA): 216007

NDA 216007 describes NALMEFENE HYDROCHLORIDE, which is a drug marketed by Chengdu Shuode and Purdue Pharma Lp and is included in two NDAs. It is available from two suppliers. Additional details are available on the NALMEFENE HYDROCHLORIDE profile page.

The generic ingredient in NALMEFENE HYDROCHLORIDE is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.

Summary for 216007

Tradename:	NALMEFENE HYDROCHLORIDE
Applicant:	Chengdu Shuode
Ingredient:	nalmefene hydrochloride
Patents:	0

Pharmacology for NDA: 216007

Mechanism of Action

Opioid Antagonists

Suppliers and Packaging for NDA: 216007

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALMEFENE HYDROCHLORIDE	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	216007	ANDA	Chengdu Shuode Pharmaceutical Co., Ltd	82432-101	82432-101-01	1 VIAL, GLASS in 1 CARTON (82432-101-01) / 1 mL in 1 VIAL, GLASS
NALMEFENE HYDROCHLORIDE	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	216007	ANDA	Chengdu Shuode Pharmaceutical Co., Ltd	82432-102	82432-102-02	1 VIAL, GLASS in 1 CARTON (82432-102-02) / 2 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:	Nov 15, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
Approval Date:	Nov 15, 2023	TE:	AP	RLD:	No

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