Assyro AI

Orange Book product · Generic (ANDA)

CEFDINIR

CEFDINIR

Generic (ANDA)ANDA 065259TE ABRX LUPIN

At a glance

May 31, 2006

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 31, 2006

    20 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFDINIR

Strength

125MG/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

AB

Application

ANDA 065259

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CEFDINIR

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.