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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076264

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NDA 076264 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Barr, Sandoz, Sun Pharma Global, Mallinckrodt, and Elite Labs, and is included in seven NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for 076264

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076264

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 076264

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride
TABLET;ORAL 076264 ANDA Mallinckrodt, Inc. 0406-1170 0406-1170-01 100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01)
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride
TABLET;ORAL 076264 ANDA Mallinckrodt, Inc. 0406-1170 0406-1170-03 30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 22, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 22, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 22, 2002TE:RLD:No


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Serving leading biopharmaceutical companies globally:

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Harvard Business School

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.

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