# SIMTRIYO
> **NDA218145** · New Drug Application · Sponsor: OTSUKA PHARMACEUTICAL CO LTD · Approved 2026-07-24
## Drug
- **FDA Application Number:** NDA218145
- **Application type:** New Drug Application
- **Brand name:** SIMTRIYO
- **Generic name:** Centanafadine Hydrochloride
- **Active ingredients:** CENTANAFADINE HYDROCHLORIDE
- **Dosage form:** CAPSULE, EXTENDED RELEASE
- **Route:** —
- **Marketing status:** Prescription
- **Sponsor:** OTSUKA PHARMACEUTICAL CO LTD
- **First approval:** 2026-07-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218145)
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