Drug application
LATUDA (LURASIDONE HYDROCHLORIDE)
Drugs@FDA NDA 200603 · SUNOVION PHARMS INC
Key facts
| Drug name | LATUDA |
|---|---|
| Active ingredients | LURASIDONE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 200603 |
| Company | SUNOVION PHARMS INC |
| Dosage forms | TABLET, ORAL |
| Strength | 40MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Oct 28, 2010 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- Yes 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: