Assyro AI

Orange Book product · Generic (ANDA)

LEVOFLOXACIN

LEVOFLOXACIN

Generic (ANDA)ANDA 077700TE ATRX RISING

At a glance

Dec 20, 2010

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 20, 2010

    15 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOFLOXACIN

Strength

0.5%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

ANDA 077700

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.