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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 Bristol Myers Squibb, Adapt Pharma, and Adapt, and is included in five NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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. Fifteen suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

Summary for NDA: 208411

Adapt Pharma
naloxone hydrochloride
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents

Pharmacology for NDA: 208411

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 208411

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naloxone hydrochloride
SPRAY, METERED;NASAL 208411 NDA Adapt Pharma, Inc. 69547-353 69547-353-02 2 VIAL, SINGLE-DOSE in 1 PACKAGE (69547-353-02) > .1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength4MG/SPRAY
Approval Date:Nov 18, 2015TE:RLD:Yes
Patent:9,211,253Patent Expiration:Mar 16, 2035Product Flag?YSubstance Flag?Delist Request?

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