APPLICATION
NDA219428
TYPE
NDA
ORIGINAL APPROVAL
2025-08-15
LATEST ACTION
2025-08-15
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TONMYA · ReferencePrescription
CYCLOBENZAPRINE HYDROCHLORIDE 2.8MG · TABLET · SUBLINGUAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.