Details for New Drug Application (NDA): 077545
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The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 077545
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Hikma Intl Pharms |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Sep 6, 2007 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
Approval Date: | Sep 6, 2007 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 24MG BASE | ||||
Approval Date: | Sep 6, 2007 | TE: | RLD: | No |
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