Orange Book product

CEFACLOR EQ 500MG BASE

Orange Book ANDA 065058 · TEVA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name CEFACLOR
Active ingredients CEFACLOR
Strength EQ 500MG BASE
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA065058
Applicant holder TEVA PHARMACEUTICALS USA INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Sep 4, 2002

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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