Application 020403
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER | ONDANSETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24914 | SUPPL | 2011-09-16 |
| 12540 | SUPPL | 2011-09-16 |
| 2483 | SUPPL | 2011-07-13 |
| 34605 | SUPPL | 2011-07-12 |
| 12539 | SUPPL | 2010-09-29 |
| 24913 | SUPPL | 2010-09-28 |
| 41338 | SUPPL | 2009-09-16 |
| 20634 | SUPPL | 2009-01-12 |
| 24912 | SUPPL | 2006-09-18 |
| 34604 | SUPPL | 2006-08-23 |
| 24911 | SUPPL | 2006-01-06 |
| 12538 | SUPPL | 2006-01-05 |
| 12537 | SUPPL | 2004-12-03 |
| 24910 | SUPPL | 2004-12-02 |
| 41337 | SUPPL | 1997-10-31 |