FdaApplication
NDA 021590
Identifiers
- fda_app_no: NDA021590
Properties
| Property | Value |
|---|---|
| applicant_name | JAZZ PHARMACEUTICALS IRELAND LTD |
| application_type | NDA |
| approval_date | 2004-02-10 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FAZACLO ODT | CLOZAPINE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| FAZACLO ODT | CLOZAPINE | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| FAZACLO ODT | CLOZAPINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| FAZACLO ODT | CLOZAPINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| FAZACLO ODT | CLOZAPINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| FAZACLO ODT | CLOZAPINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
6 products