Orange Book product

CEFPODOXIME PROXETIL EQ 200MG BASE

Orange Book ANDA 065462 · SANDOZ INC · Prescription

Key facts

Proprietary name CEFPODOXIME PROXETIL
Active ingredients CEFPODOXIME PROXETIL
Strength EQ 200MG BASE
Dosage form TABLET
Route ORAL
Application ANDA065462
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 28, 2008

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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