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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 075434

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NDA 075434 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm, 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 075434

Tradename:	NALTREXONE HYDROCHLORIDE
Applicant:	Fosun Pharma
Ingredient:	naltrexone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 8, 2000	TE:		RLD:	No

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