FdaApplication
NDA 021444
Identifiers
- fda_app_no: NDA021444
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2003-04-02 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RISPERDAL | RISPERIDONE | 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| RISPERDAL | RISPERIDONE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| RISPERDAL | RISPERIDONE | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| RISPERDAL | RISPERIDONE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| RISPERDAL | RISPERIDONE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
5 products