Orange Book product

NEXIUM EQ 20MG BASE

Orange Book NDA 021153 · ASTRAZENECA PHARMACEUTICALS LP · Prescription

Key facts

Proprietary name NEXIUM
Active ingredients ESOMEPRAZOLE MAGNESIUM
Strength EQ 20MG BASE
Dosage form CAPSULE, DELAYED REL PELLETS
Route ORAL
Application NDA021153
Applicant holder ASTRAZENECA PHARMACEUTICALS LP
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Feb 20, 2001

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)

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