FdaApplication
NDA 021526
Identifiers
- fda_app_no: NDA021526
Properties
| Property | Value |
|---|---|
| applicant_name | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA |
| application_type | NDA |
| approval_date | 2006-01-27 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RANEXA | RANOLAZINE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| RANEXA | RANOLAZINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products