FdaApplication
NDA 012093
Identifiers
- fda_app_no: NDA012093
Properties
| Property | Value |
|---|---|
| applicant_name | BAUSCH HEALTH US LLC |
| application_type | NDA |
| approval_date | 1988-07-29 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISORDIL | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL |
| ISORDIL | ISOSORBIDE DINITRATE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ISORDIL | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL |
| ISORDIL | ISOSORBIDE DINITRATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ISORDIL | ISOSORBIDE DINITRATE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
5 products