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Generated: September 23, 2017

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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 eighteen 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 NDA: 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 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	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:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 22, 2002	TE:		RLD:	No

Summary for product number 002

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

Summary 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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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.