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Last Updated: April 11, 2021

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Details for New Drug Application (NDA): 076196

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NDA 076196 describes NEFAZODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Dr Reddys Labs Inc, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Roxane, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the NEFAZODONE HYDROCHLORIDE profile page.

The generic ingredient in NEFAZODONE HYDROCHLORIDE is nefazodone hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.

Summary for 076196

Tradename:	NEFAZODONE HYDROCHLORIDE
Applicant:	Roxane
Ingredient:	nefazodone hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 16, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 16, 2003	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Sep 16, 2003	TE:		RLD:	No

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