Application 020584
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LODINE XL | ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | LODINE XL | ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | LODINE XL | ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 34884 | SUPPL | 2006-01-20 |
| 25233 | SUPPL | 2006-01-20 |
| 34883 | SUPPL | 2005-05-26 |
| 34882 | SUPPL | 2005-05-26 |
| 25232 | SUPPL | 2005-05-26 |
| 12773 | SUPPL | 2005-05-26 |
| 2782 | SUPPL | 2005-05-26 |
| 2781 | SUPPL | 2005-05-26 |
| 41447 | SUPPL | 2003-09-11 |
| 20738 | SUPPL | 2001-11-09 |
| 20737 | SUPPL | 2001-07-18 |
| 25231 | SUPPL | 2000-08-11 |
| 12772 | SUPPL | 2000-08-11 |
| 34881 | SUPPL | 1999-05-27 |
| 25230 | SUPPL | 1999-05-27 |