Orange Book product

AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG

Orange Book ANDA 091154 · TEVA PHARMACEUTICALS USA · Discontinued

Key facts

Proprietary name AMLODIPINE AND OLMESARTAN MEDOXOMIL
Active ingredients AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL
Strength EQ 5MG BASE;40MG
Dosage form TABLET
Route ORAL
Application ANDA091154
Applicant holder TEVA PHARMACEUTICALS USA
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 26, 2016

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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