FdaApplication
NDA 022008
Identifiers
- fda_app_no: NDA022008
Properties
| Property | Value |
|---|---|
| applicant_name | GLAXOSMITHKLINE LLC |
| application_type | NDA |
| approval_date | 2008-06-13 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
6 products