Assyro AI

Orange Book product · Generic (ANDA)

CEFACLOR

CEFACLOR

Generic (ANDA)ANDA 065412RX YUNG SHIN PHARM

At a glance

Feb 17, 2012

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 17, 2012

    14 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFACLOR

Strength

EQ 375MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 065412

Product number

004

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.