Drug application

EZETIMIBE (EZETIMIBE)

Drugs@FDA ANDA 208803 · AMNEAL PHARMS CO

Key facts

Drug name EZETIMIBE
Active ingredients EZETIMIBE
Application type ANDA
Application number 208803
Company AMNEAL PHARMS CO
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 12, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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

Browse all Drugs@FDA applications