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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074918

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NDA 074918 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Barr, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharma Global, and is included in seven NDAs. It is available from fifteen suppliers. Additional details are available on the NALTREXONE HYDROCHLORIDE profile page.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.
Summary for 074918
Tradename:NALTREXONE HYDROCHLORIDE
Applicant:Barr
Ingredient:naltrexone hydrochloride
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074918
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 074918
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 074918 ANDA Physicians Total Care, Inc. 54868-5574 E 54868-5574-0
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 074918 ANDA Bryant Ranch Prepack 63629-5304 E 63629-5304-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 8, 1998TE:ABRLD:No

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