Assyro AI

Orange Book product · Generic (ANDA)

CEFACLOR

CEFACLOR

Generic (ANDA)ANDA 065146RX YUNG SHIN PHARM

At a glance

Jan 22, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 22, 2004

    22 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFACLOR

Strength

EQ 500MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 065146

Product number

002

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.