Drug application

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL)

Drugs@FDA ANDA 202491 · TEVA PHARMS USA

Key facts

Drug name OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Active ingredients AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL
Application type ANDA
Application number 202491
Company TEVA PHARMS USA
Dosage forms TABLET, ORAL
Strength EQ 5MG BASE;12.5MG;20MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 3, 2016

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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