← FDA Drug Approvals (Drugs@FDA)
TONMYA
NDA · New Drug Application · Sponsor: TONIX · Approved 2025-08-15
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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