Assyro AI

Orange Book product · Generic (ANDA)

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

CIPROFLOXACIN

Generic (ANDA)ANDA 078431TE APRX HIKMA FARMACEUTICA

At a glance

Nov 18, 2009

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 18, 2009

    16 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CIPROFLOXACIN

Strength

400MG/200ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 078431

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CIPROFLOXACIN

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.