Drug application
DIROXIMEL FUMARATE (DIROXIMEL FUMARATE)
Drugs@FDA ANDA 218596 · ZYDUS
Key facts
| Drug name | DIROXIMEL FUMARATE |
|---|---|
| Active ingredients | DIROXIMEL FUMARATE |
| Application type | ANDA |
| Application number | 218596 |
| Company | ZYDUS |
| Dosage forms | CAPSULE, DELAYED RELEASE, ORAL |
| Strength | 231MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Nov 12, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
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: