FdaApplication
NDA 022033
Identifiers
- fda_app_no: NDA022033
Properties
| Property | Value |
|---|---|
| applicant_name | JAZZ PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2008-02-28 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LUVOX CR | FLUVOXAMINE MALEATE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| LUVOX CR | FLUVOXAMINE MALEATE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
2 products