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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 016636


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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 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. Fifty 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:DISCNDosage:INJECTABLE;INJECTIONStrength0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 14, 1982TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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