Jazz Pharmaceuticals plc (JAZZ)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761416 - JAZZ PHARMS | |||||||
| ZIIHERA | ZANIDATAMAB-HRII | INJECTABLE;INJECTION | 300MG | Prescription | |||
| BLA761179 - JAZZ PHARMS | |||||||
| RYLAZE | ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN | INJECTABLE;INTRAMUSCULAR | 10MG/0.5ML | Prescription | |||
| NDA213702 - JAZZ | |||||||
| ZEPZELCA | LURBINECTEDIN | POWDER;INTRAVENOUS | 4MG/VIAL | Prescription | |||
| NDA212690 - JAZZ | |||||||
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | SOLUTION;ORAL | 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | Prescription | |||
| NDA022235 - JAZZ | |||||||
| LUVOX | FLUVOXAMINE MALEATE | TABLET; ORAL | 100MG | Prescription | |||
| LUVOX | FLUVOXAMINE MALEATE | TABLET; ORAL | 50MG | Prescription | |||
| LUVOX | FLUVOXAMINE MALEATE | TABLET; ORAL | 25MG | Prescription | |||
| NDA022033 - JAZZ PHARMS | |||||||
| LUVOX CR | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LUVOX CR | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021590 - JAZZ | |||||||
| FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021196 - JAZZ PHARMS | |||||||
| XYREM | SODIUM OXYBATE | SOLUTION;ORAL | 0.5GM/ML | Prescription | |||