Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Deloitte
Chubb
US Army
Chinese Patent Office
UBS
Teva
Healthtrust
Mallinckrodt

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075274

« Back to Dashboard

NDA 075274 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 075274
Tradename:NALTREXONE HYDROCHLORIDE
Applicant:Elite Labs
Ingredient:naltrexone hydrochloride
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075274
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 075274
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274 ANDA AvKARE, Inc. 42291-632 N 42291-632-30
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274 ANDA TAGI Pharma Inc. 51224-206 N 51224-206-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 26, 1999TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
Harvard Business School
Fuji
Medtronic
Farmers Insurance
Chinese Patent Office
Accenture
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot