FdaApplication
NDA 019766
Identifiers
- fda_app_no: NDA019766
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 1991-12-23 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZOCOR | SIMVASTATIN | 5MG | TABLET;ORAL |
| ZOCOR | SIMVASTATIN | 10MG | TABLET;ORAL |
| ZOCOR | SIMVASTATIN | 20MG | TABLET;ORAL |
| ZOCOR | SIMVASTATIN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ZOCOR | SIMVASTATIN | 40MG | TABLET;ORAL |
5 products