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Generated: October 21, 2018

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, 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 076264
Tradename:NALTREXONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:naltrexone hydrochloride
Patents:0
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 SpecGx LLC 0406-1170 0406-1170-01 100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01)
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264 ANDA SpecGx LLC 0406-1170 0406-1170-03 30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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