Application 020781
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOFRAN ODT | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | Yes | No |
| 002 | ZOFRAN ODT | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 8MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0679 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0679 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0680 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0680 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82444 | SUPPL | 2025-06-04 |
| 82443 | SUPPL | 2025-06-03 |
| 69073 | SUPPL | 2021-10-22 |
| 69056 | SUPPL | 2021-10-21 |
| 67248 | SUPPL | 2021-04-29 |
| 67242 | SUPPL | 2021-04-29 |
| 54223 | SUPPL | 2018-05-17 |
| 49978 | SUPPL | 2017-10-06 |
| 49964 | SUPPL | 2017-10-06 |
| 45881 | SUPPL | 2016-11-10 |
| 45877 | SUPPL | 2016-11-10 |
| 45486 | SUPPL | 2016-09-30 |
| 25822 | SUPPL | 2014-09-23 |
| 13429 | SUPPL | 2014-09-22 |
| 3345 | SUPPL | 2013-12-13 |
| 35350 | SUPPL | 2013-12-11 |
| 44070 | ORIG | 2011-12-20 |
| 35349 | SUPPL | 2011-09-16 |
| 25821 | SUPPL | 2011-09-16 |
| 13428 | SUPPL | 2010-09-29 |
| 3344 | SUPPL | 2010-09-27 |
| 20949 | SUPPL | 2007-09-26 |
| 25820 | SUPPL | 2006-09-18 |
| 35348 | SUPPL | 2006-08-23 |
| 25819 | SUPPL | 2006-01-06 |
| 13427 | SUPPL | 2004-12-03 |
| 3343 | SUPPL | 2004-12-02 |
| 25818 | SUPPL | 2004-07-01 |
| 41698 | ORIG | 1999-01-27 |
| 25817 | ORIG | 1999-01-27 |
| 13426 | ORIG | 1999-01-27 |