Application 020103
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOFRAN | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | Yes | No |
| 002 | ZOFRAN | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 8MG BASE | Yes | No |
| 003 | ZOFRAN | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 24MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0675 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0675 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0675 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0675 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0675 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0675 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0173-0447 | ZOFRAN | ondansetron hydrochloride | GlaxoSmithKline LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82462 | SUPPL | 2025-06-04 |
| 82441 | SUPPL | 2025-06-03 |
| 69071 | SUPPL | 2021-10-22 |
| 69054 | SUPPL | 2021-10-21 |
| 67244 | SUPPL | 2021-04-29 |
| 67240 | SUPPL | 2021-04-29 |
| 49976 | SUPPL | 2017-10-06 |
| 49962 | SUPPL | 2017-10-06 |
| 45878 | SUPPL | 2016-11-10 |
| 45875 | SUPPL | 2016-11-10 |
| 45484 | SUPPL | 2016-09-30 |
| 21165 | SUPPL | 2014-09-23 |
| 12219 | SUPPL | 2014-09-22 |
| 2023 | SUPPL | 2013-12-13 |
| 34267 | SUPPL | 2013-12-11 |
| 23566 | ORIG | 2011-12-20 |
| 21164 | SUPPL | 2011-09-16 |
| 12218 | SUPPL | 2011-09-16 |
| 12217 | SUPPL | 2010-09-29 |
| 2022 | SUPPL | 2010-09-27 |
| 41145 | SUPPL | 2009-09-16 |
| 20474 | SUPPL | 2009-09-16 |
| 20473 | SUPPL | 2007-09-14 |
| 21163 | SUPPL | 2006-09-18 |
| 12216 | SUPPL | 2006-08-23 |
| 21162 | SUPPL | 2006-01-06 |
| 34266 | SUPPL | 2006-01-05 |
| 34263 | SUPPL | 2006-01-05 |
| 34265 | SUPPL | 2005-02-23 |
| 21161 | SUPPL | 2005-02-23 |
| 34264 | SUPPL | 2004-12-03 |
| 2021 | SUPPL | 2004-12-02 |
| 21160 | SUPPL | 2004-07-01 |
| 2020 | SUPPL | 2004-07-01 |
| 12215 | SUPPL | 2000-12-13 |
| 2019 | SUPPL | 2000-12-13 |
| 41144 | SUPPL | 1999-08-27 |
| 20472 | SUPPL | 1999-08-27 |