Drug application
DILANTIN-125 (PHENYTOIN)
Drugs@FDA NDA 008762 · VIATRIS
Key facts
| Drug name | DILANTIN-125 |
|---|---|
| Active ingredients | PHENYTOIN |
| Application type | NDA |
| Application number | 008762 |
| Company | VIATRIS |
| Dosage forms | SUSPENSION, ORAL |
| Strength | 125MG/5ML |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 2 - New Active Ingredient |
| Latest submission status date | Jan 6, 1953 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 1–9 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: