FdaApplication
NDA 021875
Identifiers
- fda_app_no: NDA021875
Properties
| Property | Value |
|---|---|
| applicant_name | NUVO PHARMACEUTICALS (IRELAND) DAC |
| application_type | NDA |
| approval_date | 2007-06-15 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NUVIGIL | ARMODAFINIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| NUVIGIL | ARMODAFINIL | 150MG | TABLET;ORAL |
| NUVIGIL | ARMODAFINIL | 250MG | TABLET;ORAL |
| NUVIGIL | ARMODAFINIL | 200MG | TABLET;ORAL |
| NUVIGIL | ARMODAFINIL | 50MG | TABLET;ORAL |
5 products