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FDA NDA · NDA216564

FLAVALTA

lidocaine hydrochloride and epinephrine

Sponsor: DEPROCO

APPLICATION
NDA216564
TYPE
NDA
ORIGINAL APPROVAL
2026-03-19
LATEST ACTION
2026-03-19
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FLAVALTA · ReferencePrescription
EPINEPHRINE BITARTRATE EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML), LIDOCAINE HYDROCHLORIDE 34MG/1.7ML (20MG/ML) · SOLUTION · INJECTION

Approval history

2026-03-19Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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