Last Updated: September 25, 2026

Details for New Drug Application (NDA): 072193


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NDA 072193 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Crossmedika Sa, Granules, Graviti Pharms, Natco, Oxford Pharms, Pharmobedient, Pliva, Quantum Pharmics, Rising, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms, and is included in thirty-two NDAs. It is available from thirty-seven suppliers. Additional details are available on the TRAZODONE HYDROCHLORIDE profile page.

The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There is one drug master file entry for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 072193
Tradename:TRAZODONE HYDROCHLORIDE
Applicant:Oxford Pharms
Ingredient:trazodone hydrochloride
Patents:0
Pharmacology for NDA: 072193
Medical Subject Heading (MeSH) Categories for 072193
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 072193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 072193 ANDA TRUPHARMA LLC 52817-395 52817-395-10 100 TABLET, FILM COATED in 1 BOTTLE (52817-395-10)
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 072193 ANDA TRUPHARMA LLC 52817-396 52817-396-10 100 TABLET, FILM COATED in 1 BOTTLE (52817-396-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Feb 2, 1989TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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