FdaApplication
NDA 019471
Identifiers
- fda_app_no: NDA019471
Properties
| Property | Value |
|---|---|
| applicant_name | BIOVAIL LABORATORIES INC |
| application_type | NDA |
| approval_date | 1989-01-23 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
4 products