Details for New Drug Application (NDA): 016636

NDA 016636 describes NARCAN, which is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent, and is included in five NDAs. It is available from six suppliers. There are two patents protecting this drug and two Paragraph IV challenges. 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-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

Summary for 016636

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

Medical Subject Heading (MeSH) Categories for 016636

Narcotic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jun 14, 1982	TE:		RLD:	Yes

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