Details for New Drug Application (NDA): 020103
NDA 020103 describes ZOFRAN, which is a drug marketed by Sandoz and Glaxosmithkline and is included in five NDAs. Additional details are available on the ZOFRAN profile page.
The generic ingredient in ZOFRAN is ondansetron. There are two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
The generic ingredient in ZOFRAN is ondansetron. There are two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020103
| Tradename: | ZOFRAN |
| Applicant: | Sandoz |
| Ingredient: | ondansetron hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 31, 1992 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 31, 1992 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 27, 1999 | TE: | RLD: | Yes | |||||
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