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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 Sandoz, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Mylan, Teva, Ivax Sub Teva Pharms, Idt Australia Ltd, Watson Labs, and Roxane, and is included in nine NDAs. It is available from four suppliers. Additional details are available on the NEFAZODONE HYDROCHLORIDE profile page.

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

Summary for NDA: 076196

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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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