Assyro AI

Orange Book product · Generic (ANDA)

CIPROFLOXACIN EXTENDED RELEASE

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Generic (ANDA)ANDA 078712DISCN FOSUN PHARMA

At a glance

Dec 11, 2007

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 11, 2007

    18 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Strength

212.6MG;EQ 287.5MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 078712

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

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.