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Orange Book product · Generic (ANDA)

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Generic (ANDA)ANDA 079138DISCN HOSPIRA

At a glance

Jun 18, 2010

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 18, 2010

    16 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Strength

4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 079138

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.