Application 019583
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RELAFEN | NABUMETONE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | RELAFEN | NABUMETONE | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 1399 | SUPPL | 2006-01-30 |
| 33803 | SUPPL | 2006-01-25 |
| 11542 | SUPPL | 2005-08-15 |
| 1398 | SUPPL | 2005-08-15 |