Orange Book product · Brand (NDA)

SEPTOCAINE

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand (NDA)NDA 020971RX DEPROCO

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

At a glance

Mar 30, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 30, 2006
20 yr 6 mo ago
Today

Pharmaceutical detail

Active ingredient

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Strength

4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 020971

Product number

002

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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