FdaApplication
NDA 020658
Identifiers
- fda_app_no: NDA020658
Properties
| Property | Value |
|---|---|
| applicant_name | GLAXOSMITHKLINE LLC |
| application_type | NDA |
| approval_date | 1997-09-19 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| REQUIP | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
7 products