Assyro AI

Orange Book product · Brand (NDA)

FLOXIN

OFLOXACIN

Brand (NDA)NDA 020087DISCN ORTHO MCNEIL PHARM

At a glance

Mar 31, 1992

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 31, 1992

    34 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OFLOXACIN

Strength

20MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 020087

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.