Assyro AI

Orange Book product · Generic (ANDA)

CEFACLOR

CEFACLOR

Generic (ANDA)ANDA 065057DISCN WORLD GEN

At a glance

Jan 05, 2001

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 05, 2001

    25 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFACLOR

Strength

EQ 500MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 065057

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CEFACLOR

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.