Drug application
TEGRETOL (CARBAMAZEPINE)
Drugs@FDA NDA 018281 · NOVARTIS
Key facts
| Drug name | TEGRETOL |
|---|---|
| Active ingredients | CARBAMAZEPINE |
| Application type | NDA |
| Application number | 018281 |
| Company | NOVARTIS |
| Dosage forms | TABLET, CHEWABLE, ORAL |
| Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |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 3 - New Dosage Form |
| Latest submission status date | Dec 14, 1981 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 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: