Details for New Drug Application (NDA): 020007
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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 are twenty-eight drug master file entries for this compound. Sixty-seven 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 are twenty-eight drug master file entries for this compound. Sixty-seven 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INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Expired US Patents for NDA 020007
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ZOFRAN | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-001 | Jan 4, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-003 | Dec 10, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-003 | Dec 10, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-003 | Dec 10, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-001 | Jan 4, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-001 | Jan 4, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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