Drug application
DILANTIN (PHENYTOIN SODIUM)
Drugs@FDA ANDA 084349 · VIATRIS
Key facts
| Drug name | DILANTIN |
|---|---|
| Active ingredients | PHENYTOIN SODIUM |
| Application type | ANDA |
| Application number | 084349 |
| Company | VIATRIS |
| Dosage forms | CAPSULE, ORAL |
| Strength | 30MG EXTENDED |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission status date | Aug 27, 1976 |
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: