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Last Updated: February 18, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071523

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NDA 071523 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, Oxford Pharms, Pliva, Quantum Pharmics, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from thirty-four suppliers. Additional details are available on the TRAZODONE HYDROCHLORIDE profile page.

The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 071523
Applicant:Teva Pharms Usa
Ingredient:trazodone hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 071523
Suppliers and Packaging for NDA: 071523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071523 ANDA KAISER FOUNDATION HOSPITALS 0179-1118 0179-1118-30 30 TABLET in 1 BOTTLE (0179-1118-30)
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071523 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2578 0615-2578-05 15 TABLET in 1 BLISTER PACK (0615-2578-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 11, 1987TE:ABRLD:No

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Boehringer Ingelheim

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