Application 020605
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOFRAN | ONDANSETRON HYDROCHLORIDE | SOLUTION;ORAL | EQ 4MG BASE/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0489 | ZOFRAN | ondansetron hydrochloride | GlaxoSmithKline LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82463 | SUPPL | 2025-06-04 |
| 82442 | SUPPL | 2025-06-03 |
| 69072 | SUPPL | 2021-10-22 |
| 69055 | SUPPL | 2021-10-21 |
| 67246 | SUPPL | 2021-04-29 |
| 67241 | SUPPL | 2021-04-29 |
| 49977 | SUPPL | 2017-10-06 |
| 49963 | SUPPL | 2017-10-06 |
| 45879 | SUPPL | 2016-11-10 |
| 45876 | SUPPL | 2016-11-10 |
| 45485 | SUPPL | 2016-09-30 |
| 2863 | SUPPL | 2014-09-23 |
| 34949 | SUPPL | 2014-09-22 |
| 25309 | SUPPL | 2013-12-13 |
| 12836 | SUPPL | 2013-12-11 |
| 44061 | ORIG | 2011-12-20 |
| 25308 | SUPPL | 2011-09-16 |
| 12835 | SUPPL | 2011-09-16 |
| 12834 | SUPPL | 2010-09-29 |
| 2862 | SUPPL | 2010-09-27 |
| 41477 | SUPPL | 2009-09-16 |
| 20761 | SUPPL | 2007-09-26 |
| 25307 | SUPPL | 2006-09-18 |
| 12833 | SUPPL | 2006-08-23 |
| 25306 | SUPPL | 2006-01-06 |
| 12832 | SUPPL | 2006-01-05 |
| 12831 | SUPPL | 2004-12-03 |
| 2861 | SUPPL | 2004-12-02 |
| 12830 | SUPPL | 2000-12-13 |
| 2860 | SUPPL | 2000-12-13 |
| 41476 | ORIG | 1997-01-24 |