# TONMYA
> **NDA219428** · New Drug Application · Sponsor: TONIX · Approved 2025-08-15
## Drug
- **FDA Application Number:** NDA219428
- **Application type:** New Drug Application
- **Brand name:** TONMYA
- **Generic name:** CYCLOBENZAPRINE HYDROCHLORIDE
- **Active ingredients:** CYCLOBENZAPRINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** SUBLINGUAL
- **Marketing status:** Prescription
- **Sponsor:** TONIX
- **Manufacturer:** Tonix Medicines, Inc.
- **First approval:** 2025-08-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219428)
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