Orange Book product

OLMESARTAN MEDOXOMIL 20MG

Orange Book ANDA 204814 · MACLEODS PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name OLMESARTAN MEDOXOMIL
Active ingredients OLMESARTAN MEDOXOMIL
Strength 20MG
Dosage form TABLET
Route ORAL
Application ANDA204814
Applicant holder MACLEODS PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 24, 2017

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)

Browse all Orange Book products