Orange Book product

ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE

Orange Book ANDA 217022 · ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD · Prescription

Key facts

Proprietary name ESOMEPRAZOLE MAGNESIUM
Active ingredients ESOMEPRAZOLE MAGNESIUM
Strength EQ 20MG BASE
Dosage form CAPSULE, DELAYED REL PELLETS
Route ORAL
Application ANDA217022
Applicant holder ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 27, 2023

At a glance

  • 10–99 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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