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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073137

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NDA 073137 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurolife Pharma Llc, Fosun Pharma, Mylan, Mylan Pharms Inc, Pliva, Quantum Pharmics, 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-three 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-three suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 073137
Tradename:TRAZODONE HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:trazodone hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 073137
Suppliers and Packaging for NDA: 073137
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 073137 ANDA Sun Pharmaceutical Industries, Inc. 53489-510 N 53489-510-01
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 073137 ANDA Sun Pharmaceutical Industries, Inc. 53489-510 N 53489-510-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 24, 1993TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 24, 1993TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 22, 1995TE:ABRLD:No

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