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Details for New Drug Application (NDA): 076196
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The generic ingredient in NEFAZODONE HYDROCHLORIDE is nefazodone hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.
Summary for 076196
Tradename: | NEFAZODONE HYDROCHLORIDE |
Applicant: | Roxane |
Ingredient: | nefazodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 16, 2003 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 16, 2003 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Sep 16, 2003 | TE: | RLD: | No |
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