Details for New Drug Application (NDA): 020781
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NDA 020781 describes ZOFRAN ODT, which is a drug marketed by Sandoz and is included in one NDA. Additional details are available on the ZOFRAN ODT profile page.
The generic ingredient in ZOFRAN ODT is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
The generic ingredient in ZOFRAN ODT is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020781
| Tradename: | ZOFRAN ODT |
| Applicant: | Sandoz |
| Ingredient: | ondansetron |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020781
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 27, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 27, 1999 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020781
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-002 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-002 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-002 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-002 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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