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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 071196


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NDA 071196 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Crossmedika Sa, Fosun Pharma, Granules, Graviti Pharms, Natco, Norvium Bioscience, Oxford Pharms, 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 071196
Tradename:TRAZODONE HYDROCHLORIDE
Applicant:Apotex Inc
Ingredient:trazodone hydrochloride
Patents:0
Pharmacology for NDA: 071196
Suppliers and Packaging for NDA: 071196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071196 ANDA Teva Pharmaceuticals USA, Inc. 0555-0711 0555-0711-02 100 TABLET in 1 BOTTLE (0555-0711-02)
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071196 ANDA Apotex Corp 60505-2654 60505-2654-0 10 BLISTER PACK in 1 CARTON (60505-2654-0) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 25, 1987TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 26, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Apr 26, 1999TE:ABRLD:No

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