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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 072192


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NDA 072192 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Fosun Pharma, Mylan, Mylan Pharms Inc, 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 twenty-nine NDAs. It is available from thirty-six 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-six suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 072192
Tradename:TRAZODONE HYDROCHLORIDE
Applicant:Oxford Pharms
Ingredient:trazodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072192
Suppliers and Packaging for NDA: 072192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 072192 ANDA Medsource Pharmaceuticals 45865-431 45865-431-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-431-30)
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 072192 ANDA Medsource Pharmaceuticals 45865-431 45865-431-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-431-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 2, 1989TE:ABRLD:No

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