Orange Book product

CEPHALEXIN EQ 500MG BASE

Orange Book ANDA 090836 · ALKEM LABORATORIES LTD · Prescription

Key facts

Proprietary name CEPHALEXIN
Active ingredients CEPHALEXIN
Strength EQ 500MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA090836
Applicant holder ALKEM LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 20, 2010

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)

Browse all Orange Book products