Assyro AI

Orange Book product · Generic (ANDA)

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

LEVOFLOXACIN

Generic (ANDA)ANDA 091375TE APRX HIKMA FARMACEUTICA

At a glance

Sep 16, 2011

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 16, 2011

    15 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOFLOXACIN

Strength

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

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 091375

Product number

001

Marketing status

RX

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.