Drug application

OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)

Drugs@FDA ANDA 206455 · CHARTWELL

Key facts

Drug name OMEGA-3-ACID ETHYL ESTERS
Active ingredients OMEGA-3-ACID ETHYL ESTERS
Application type ANDA
Application number 206455
Company CHARTWELL
Dosage forms CAPSULE, ORAL
Strength 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 7, 2019

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

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