Assyro AI

Orange Book product · Generic (ANDA)

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

LEVOFLOXACIN

Generic (ANDA)ANDA 206919DISCN EUGIA PHARMA

At a glance

Feb 10, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 10, 2016

    10 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOFLOXACIN

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 206919

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVOFLOXACIN

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.