Drug application
ISORDIL (ISOSORBIDE DINITRATE)
Drugs@FDA NDA 012940 · BIOVAIL
Key facts
| Drug name | ISORDIL |
|---|---|
| Active ingredients | ISOSORBIDE DINITRATE |
| Application type | NDA |
| Application number | 012940 |
| Company | BIOVAIL |
| Dosage forms | TABLET, SUBLINGUAL |
| Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Dec 20, 1961 |
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: