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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Farmers Insurance

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090356

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NDA 090356 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 090356
Applicant:Sun Pharma Global
Ingredient:naltrexone hydrochloride
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090356
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 090356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 090356 ANDA Sun Pharma Global FZE 47335-326 N 47335-326-18
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 090356 ANDA Sun Pharma Global FZE 47335-326 N 47335-326-83

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 24, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Johnson and Johnson

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