Drug application
LUMATEPERONE TOSYLATE (LUMATEPERONE)
Drugs@FDA ANDA 218652 · ZYDUS PHARMACEUTICALS (USA) INC.
Key facts
| Drug name | LUMATEPERONE TOSYLATE |
|---|---|
| Active ingredients | LUMATEPERONE |
| Application type | ANDA |
| Application number | 218652 |
| Company | ZYDUS PHARMACEUTICALS (USA) INC. |
| Dosage forms | CAPSULE |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Sep 1, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- None 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.