Details for New Drug Application (NDA): 071258
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NDA 071258 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-five 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.
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 071258
| Tradename: | TRAZODONE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | trazodone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071258
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 071258 | ANDA | Apotex Corp | 60505-2653 | 60505-2653-0 | 10 BLISTER PACK in 1 CARTON (60505-2653-0) / 10 TABLET in 1 BLISTER PACK |
| TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 071258 | ANDA | Apotex Corp | 60505-2653 | 60505-2653-1 | 100 TABLET in 1 BOTTLE (60505-2653-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 25, 1987 | TE: | AB | RLD: | No | ||||
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