FdaApplication
NDA 021485
Identifiers
- fda_app_no: NDA021485
Properties
| Property | Value |
|---|---|
| applicant_name | ORION PHARMA |
| application_type | NDA |
| approval_date | 2003-06-11 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| STALEVO 100 | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL |
| STALEVO 125 | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET;ORAL |
| STALEVO 150 | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL |
| STALEVO 200 | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET;ORAL |
| STALEVO 50 | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL |
| STALEVO 75 | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET;ORAL |
6 products