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Last Updated: January 21, 2020

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Details for New Drug Application (NDA): 208411

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NDA 208411 describes NARCAN, which is a drug marketed by Adapt and Bristol Myers Squibb and is included in five NDAs. It is available from two suppliers. There are eight 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. Twenty suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 208411
Tradename:NARCAN
Applicant:Adapt
Ingredient:naloxone hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 208411
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 208411
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 Lake Erie Medical DBA Quality Care Products LLC 55700-457 55700-457-01 2 VIAL, SINGLE-DOSE in 1 PACKAGE (55700-457-01) > .1 mL in 1 VIAL, SINGLE-DOSE
NARCAN naloxone hydrochloride SPRAY, METERED;NASAL 208411 NDA Adapt Pharma Inc 69547-212 69547-212-04 4 VIAL, SINGLE-DOSE in 1 PACKAGE (69547-212-04) > .1 mL in 1 VIAL, SINGLE-DOSE
Paragraph IV (Patent) Challenges for 208411
Tradename Dosage Ingredient NDA Submissiondate
NARCAN SPRAY, METERED;NASAL naloxone hydrochloride 208411 2016-07-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength4MG/SPRAY
Approval Date:Nov 18, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 16, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
Patent:  Start TrialPatent Expiration:Mar 16, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 16, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKesson
Mallinckrodt
Harvard Business School
Moodys

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