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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 073137


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NDA 073137 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, 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-nine 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-nine 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
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. 57664-014 57664-014-72 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72)
TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 073137 ANDA Sun Pharmaceutical Industries, Inc. 57664-014 57664-014-74 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74)

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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