Details for New Drug Application (NDA): 071196
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NDA 071196 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.
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 071196
| Tradename: | TRAZODONE HYDROCHLORIDE |
| Applicant: | Apotex Inc |
| Ingredient: | trazodone hydrochloride |
| Patents: | 0 |
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: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 25, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 26, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Apr 26, 1999 | TE: | AB | RLD: | No | ||||
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