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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Covington
Cipla
Moodys
McKesson
Argus Health
Merck
US Department of Justice
Novartis

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071258

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NDA 071258 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurolife Pharma Llc, Mylan, Mylan Pharms Inc, Pliva, Quantum Pharmics, Sandoz, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent Pharms Ltd, Usl Pharma, Vintage, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-eight NDAs. It is available from forty-six suppliers. Additional details are available on the TRAZODONE HYDROCHLORIDE profile page.

The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There are thirteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 071258
Tradename:TRAZODONE HYDROCHLORIDE
Applicant:Apotex
Ingredient:trazodone hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 071258
Suppliers and Packaging for NDA: 071258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071258 ANDA Major Pharmaceuticals 0904-6554 0904-6554-61 100 BLISTER PACK in 1 CARTON (0904-6554-61) > 1 TABLET in 1 BLISTER PACK
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071258 ANDA STAT Rx USA LLC 42549-546 42549-546-30 30 TABLET in 1 BOTTLE (42549-546-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 25, 1987TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Healthtrust
Cerilliant
US Army
US Department of Justice
Chubb

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