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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076072

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NDA 076072 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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.

Summary for 076072

Tradename:	NEFAZODONE HYDROCHLORIDE
Applicant:	Ani Pharms
Ingredient:	nefazodone hydrochloride
Patents:	0

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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