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Naltrexone hydrochloride - Generic Drug Details

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Naltrexone hydrochloride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Barr, Teva Womens, Sandoz, Sun Pharma Global, Mallinckrodt, Elite Labs, and Pfizer Inc, and is included in eight NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for naltrexone hydrochloride. Thirteen suppliers are listed for this compound.

Summary for Generic Name: naltrexone hydrochloride

Drug Master File Entries: see list17
Suppliers / Packaging: see list13
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Drug Prices:see low prices

Pharmacology for Ingredient: naltrexone hydrochloride

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

Clinical Trials for: naltrexone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
naltrexone hydrochloride
TABLET;ORAL076264-003Mar 22, 2002RXNo
Pfizer Inc
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-004Aug 19, 2016RXNo8,685,443Jul 3, 2025
Elite Labs
naltrexone hydrochloride
TABLET;ORAL075274-001May 26, 1999RXNo
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