Drug application
TECZEM (DILTIAZEM MALATE, ENALAPRIL MALEATE)
Drugs@FDA NDA 020507 · BIOVAIL
Key facts
| Drug name | TECZEM |
|---|---|
| Active ingredients | DILTIAZEM MALATE, ENALAPRIL MALEATE |
| Application type | NDA |
| Application number | 020507 |
| Company | BIOVAIL |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | EQ 180MG HYDROCHLORIDE;5MG |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 2 New Active Ingredient and Type 4 New Combination |
| Latest submission status date | Oct 4, 1996 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: