FdaApplication
NDA 019309
Identifiers
- fda_app_no: NDA019309
Properties
| Property | Value |
|---|---|
| applicant_name | BIOVAIL LABORATORIES INTERNATIONAL SRL |
| application_type | NDA |
| approval_date | 1988-02-09 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VASOTEC | ENALAPRILAT | 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
1 product