Details for New Drug Application (NDA): 071196
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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 071196
Tradename: | TRAZODONE HYDROCHLORIDE |
Applicant: | Apotex Inc |
Ingredient: | trazodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | A-S Medication Solutions | 50090-2373 | 50090-2373-0 | 30 TABLET in 1 BOTTLE (50090-2373-0) |
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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