FdaApplication
NDA 020027
Identifiers
- fda_app_no: NDA020027
Properties
| Property | Value |
|---|---|
| applicant_name | BIOVAIL LABORATORIES INTERNATIONAL SRL |
| application_type | NDA |
| approval_date | 1991-10-24 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
2 products