Details for New Drug Application (NDA): 020007
NDA 020007 describes ZOFRAN PRESERVATIVE FREE, which is a drug marketed by Sandoz and is included in one NDA. Additional details are available on the ZOFRAN PRESERVATIVE FREE profile page.
The generic ingredient in ZOFRAN PRESERVATIVE FREE is ondansetron hydrochloride. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
The generic ingredient in ZOFRAN PRESERVATIVE FREE is ondansetron hydrochloride. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 020007
| Tradename: | ZOFRAN PRESERVATIVE FREE |
| Applicant: | Sandoz |
| Ingredient: | ondansetron hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 4, 1991 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 10, 1993 | TE: | RLD: | Yes | |||||
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