Last Updated: August 3, 2026

Details for New Drug Application (NDA): 213195

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NDA 213195 describes NALTREXONE, which is a drug marketed by Teva Pharms Usa Inc, Accord Hlthcare, Barr, Chartwell, Elite Labs, Novitium Pharma, Specgx Llc, and Sun Pharm, and is included in eight NDAs. Additional details are available on the NALTREXONE profile page.

The generic ingredient in NALTREXONE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for 213195

Tradename:	NALTREXONE
Applicant:	Teva Pharms Usa Inc
Ingredient:	naltrexone
Patents:	0

Medical Subject Heading (MeSH) Categories for 213195

Narcotic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	380MG/VIAL
Approval Date:	Jul 6, 2023	TE:		RLD:	No

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