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FLAVALTA

NDA · New Drug Application · Sponsor: DEPROCO · Approved 2026-03-19

Drug application

FDA Application #

NDA216564

Application type

New Drug Application

Brand name

FLAVALTA

Generic name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Active ingredients

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

INJECTION

Marketing status

Prescription

Sponsor

DEPROCO

Manufacturer

Septodont, Inc.

First approval

2026-03-19

Source

Authoritative

Drugs@FDA application overview

Machine

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