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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 24, 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 fourteen 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. Fourteen 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
Therapeutic Class:	Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 076264

Mechanism of Action	Opioid 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	N	0406-1170-03
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	076264	ANDA	SpecGx LLC	0406-1170	N	0406-1170-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 22, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 22, 2002	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 22, 2002	TE:		RLD:	No

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