Orange Book product · Brand (NDA)

FLAVALTA

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Brand (NDA)NDA 216564RX DEPROCO

View EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Mar 19, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 19, 2026
3 mo ago
Today

Pharmaceutical detail

Active ingredient

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Strength

EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)

Dosage form

SOLUTION

Route

INJECTION

TE code

Not listed

Application

NDA 216564

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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