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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219428
Company: TONIX

Products on NDA 219428

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TONMYA	CYCLOBENZAPRINE HYDROCHLORIDE	2.8MG	TABLET;SUBLINGUAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/2025	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219428Orig1s000ltr.pdf

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