FdaApplication
NDA 019583
Identifiers
- fda_app_no: NDA019583
Properties
| Property | Value |
|---|---|
| applicant_name | SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE |
| application_type | NDA |
| approval_date | 1991-12-24 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RELAFEN | NABUMETONE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| RELAFEN | NABUMETONE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products