| 761416 | BLA | JAZZ PHARMS | | 001 | ZIIHERA | INJECTABLE;INJECTION | 300MG | ZANIDATAMAB-HRII | 2024-11-20 | Prescription | No |
| 761179 | BLA | JAZZ PHARMS | | 001 | RYLAZE | INJECTABLE;INTRAMUSCULAR | 10MG/0.5ML | ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN | 2021-06-30 | Prescription | No |
| 212690 | NDA | JAZZ | | 001 | XYWAV | SOLUTION;ORAL | 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | 2020-07-21 | Prescription | Yes |
| 213702 | NDA | JAZZ | | 001 | ZEPZELCA | POWDER;INTRAVENOUS | 4MG/VIAL | LURBINECTEDIN | 2020-06-15 | Prescription | Yes |
| 210365 | NDA | JAZZ PHARMS RES | | 001 | EPIDIOLEX | SOLUTION;ORAL | 100MG/ML | CANNABIDIOL | 2018-06-25 | Prescription | Yes |
| 209401 | NDA | JAZZ PHARMS THERAP | | 001 | VYXEOS | POWDER;INTRAVENOUS | 100MG;44MG | CYTARABINE; DAUNORUBICIN | 2017-08-03 | Prescription | Yes |
| 208114 | NDA | JAZZ PHARMS INC | | 001 | DEFITELIO | SOLUTION;INTRAVENOUS | 200MG/2.5ML (80MG/ML) | DEFIBROTIDE SODIUM | 2016-03-30 | Prescription | Yes |
| 022235 | NDA | JAZZ | | 001 | LUVOX | TABLET; ORAL | 25MG | FLUVOXAMINE MALEATE | 2008-04-14 | Prescription | No |
| 002 | LUVOX | TABLET; ORAL | 50MG | FLUVOXAMINE MALEATE | 2008-04-14 | Prescription | No |
| 003 | LUVOX | TABLET; ORAL | 100MG | FLUVOXAMINE MALEATE | 2008-04-14 | Prescription | No |
| 022033 | NDA | JAZZ PHARMS | | 001 | LUVOX CR | CAPSULE, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FLUVOXAMINE MALEATE | 2008-02-28 | Discontinued | No |
| 002 | LUVOX CR | CAPSULE, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FLUVOXAMINE MALEATE | 2008-02-28 | Discontinued | No |
| 021590 | NDA | JAZZ | | 001 | FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CLOZAPINE | 2004-02-10 | Discontinued | No |
| 002 | FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CLOZAPINE | 2004-02-10 | Discontinued | No |
| 003 | FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CLOZAPINE | 2004-02-10 | Discontinued | No |
| 004 | FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CLOZAPINE | 2004-02-10 | Discontinued | No |
| 005 | FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CLOZAPINE | 2004-02-10 | Discontinued | No |
| 006 | FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CLOZAPINE | 2004-02-10 | Discontinued | No |
| 021196 | NDA | JAZZ PHARMS | | 001 | XYREM | SOLUTION;ORAL | 0.5GM/ML | SODIUM OXYBATE | 2002-07-17 | Prescription | Yes |