Drug application
VORTIOXETINE HYDROBROMIDE (VORTIOXETINE)
Drugs@FDA ANDA 211165 · MACLEODS PHARMACEUTICALS LTD
Key facts
| Drug name | VORTIOXETINE HYDROBROMIDE |
|---|---|
| Active ingredients | VORTIOXETINE |
| Application type | ANDA |
| Application number | 211165 |
| Company | MACLEODS PHARMACEUTICALS LTD |
| Dosage forms | TABLET:FILM COATED |
| Strength | 20MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Nov 10, 2025 |
At a glance
- 1–9 Submissions
- None 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.