Orange Book product

CEFACLOR EQ 187MG BASE/5ML

Orange Book ANDA 065412 · YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD · Prescription

Key facts

Proprietary name CEFACLOR
Active ingredients CEFACLOR
Strength EQ 187MG BASE/5ML
Dosage form FOR SUSPENSION
Route ORAL
Application ANDA065412
Applicant holder YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 17, 2012

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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