Application 020776
- Type
- NDA
- Sponsor
- GD SEARLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAYPRO ALTA | OXAPROZIN POTASSIUM | TABLET;ORAL | 600MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80379 | SUPPL | 2024-11-25 |
| 80378 | SUPPL | 2024-11-25 |
| 80282 | SUPPL | 2024-11-22 |
| 73536 | SUPPL | 2022-11-09 |
| 67350 | SUPPL | 2021-05-03 |
| 67349 | SUPPL | 2021-05-03 |
| 67256 | SUPPL | 2021-04-29 |
| 58592 | SUPPL | 2019-05-07 |
| 58580 | SUPPL | 2019-05-06 |
| 58579 | SUPPL | 2019-05-06 |
| 3318 | SUPPL | 2016-05-12 |
| 13399 | SUPPL | 2016-05-11 |
| 23187 | ORIG | 2009-11-18 |
| 25774 | SUPPL | 2007-07-10 |
| 35318 | SUPPL | 2006-01-20 |
| 25773 | SUPPL | 2006-01-20 |
| 20932 | ORIG | 2005-04-27 |
| 25772 | ORIG | 2002-10-17 |
| 13398 | ORIG | 2002-10-17 |