Last Updated: November 9, 2026

Details for New Drug Application (NDA): 076129

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NDA 076129 describes NEFAZODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Roxane, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the NEFAZODONE HYDROCHLORIDE profile page.

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

Summary for 076129

Tradename:	NEFAZODONE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Usa
Ingredient:	nefazodone hydrochloride
Patents:	0

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

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 16, 2003	TE:		RLD:	No

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