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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076037


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NDA 076037 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 are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.
Summary for 076037
Tradename:NEFAZODONE HYDROCHLORIDE
Applicant:Teva
Ingredient:nefazodone hydrochloride
Patents:0
Pharmacology for NDA: 076037
Suppliers and Packaging for NDA: 076037
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076037 ANDA Teva Pharmaceuticals USA, Inc. 0093-1024 0093-1024-06 60 TABLET in 1 BOTTLE (0093-1024-06)
NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076037 ANDA Teva Pharmaceuticals USA, Inc. 0093-1025 0093-1025-06 60 TABLET in 1 BOTTLE (0093-1025-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 16, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 16, 2003TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 16, 2003TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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