FdaApplication
NDA 012940
Identifiers
- fda_app_no: NDA012940
Properties
| Property | Value |
|---|---|
| applicant_name | BIOVAIL LABORATORIES INC |
| application_type | NDA |
| approval_date | 1988-07-29 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISORDIL | ISOSORBIDE DINITRATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL |
| ISORDIL | ISOSORBIDE DINITRATE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL |
| ISORDIL | ISOSORBIDE DINITRATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL |
3 products