Assyro AI

Orange Book product · Generic (ANDA)

CEFACLOR

CEFACLOR

Generic (ANDA)ANDA 064087DISCN IVAX SUB TEVA PHARMS

At a glance

Apr 28, 1995

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 28, 1995

    31 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFACLOR

Strength

EQ 125MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 064087

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.