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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091205

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NDA 091205 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Novitium Pharma, Specgx Llc, and Sun Pharm, and is included in seven NDAs. It is available from nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for 091205

Tradename:	NALTREXONE HYDROCHLORIDE
Applicant:	Accord Hlthcare
Ingredient:	naltrexone hydrochloride
Patents:	0

Pharmacology for NDA: 091205

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 091205

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	091205	ANDA	Accord Healthcare, Inc.	16729-081	16729-081-01	100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	091205	ANDA	Accord Healthcare, Inc.	16729-081	16729-081-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 17, 2011	TE:	AB	RLD:	No

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