Details for New Drug Application (NDA): 208411

NDA 208411 describes NARCAN, which is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent, and is included in five NDAs. It is available from five suppliers. Additional details are available on the NARCAN profile page.

The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

Summary for 208411

Tradename:	NARCAN
Applicant:	Emergent
Ingredient:	naloxone hydrochloride
Patents:	0

Pharmacology for NDA: 208411

Mechanism of Action

Opioid Antagonists

Medical Subject Heading (MeSH) Categories for 208411

Narcotic Antagonists

Suppliers and Packaging for NDA: 208411

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411	NDA	A-S Medication Solutions	50090-2422	50090-2422-0	2 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-2422-0) / .1 mL in 1 VIAL, SINGLE-DOSE
NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-5908	50090-5908-0	2 VIAL, SINGLE-DOSE in 1 CARTON (50090-5908-0) / .1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPRAY, METERED;NASAL			Strength	4MG/SPRAY
Approval Date:	Nov 18, 2015	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jan 24, 2017	TE:		RLD:	Yes

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