Orange Book product

PROTONIX EQ 40MG BASE

Orange Book NDA 020987 · WYETH PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name PROTONIX
Active ingredients PANTOPRAZOLE SODIUM
Strength EQ 40MG BASE
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Application NDA020987
Applicant holder WYETH PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Feb 2, 2000

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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