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Generated: May 27, 2017

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Details for New Drug Application (NDA): 071196

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NDA 071196 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Mylan, Watson Labs, Alvogen, Mylan Pharms Inc, Quantum Pharmics, Teva Pharms Usa, Pliva, Sun Pharm Inds, Am Therap, Teva, Apotex, Torrent Pharms Ltd, Sandoz, Aurolife Pharma Llc, Usl Pharma, Vintage, and Apotex Inc, and is included in twenty-six NDAs. It is available from forty-six suppliers. Additional details are available on the TRAZODONE HYDROCHLORIDE profile page.

The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There are thirteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

Summary for NDA: 071196

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

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
TABLET;ORAL 071196 ANDA Teva Pharmaceuticals USA, Inc.. 0555-0733 0555-0733-02 100 TABLET in 1 BOTTLE (0555-0733-02)
trazodone hydrochloride
TABLET;ORAL 071196 ANDA Major Pharmaceuticals 0904-6555 0904-6555-61 100 BLISTER PACK in 1 CARTON (0904-6555-61) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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