Assyro AI

Orange Book product · Generic (ANDA)

LEVOFLOXACIN

LEVOFLOXACIN

Generic (ANDA)ANDA 078577DISCN HOSPIRA

At a glance

Aug 12, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 12, 2015

    11 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOFLOXACIN

Strength

EQ 500MG/20ML (EQ 25MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 078577

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.