Drug application

ESZOPICLONE (ESZOPICLONE)

Drugs@FDA ANDA 208451 · AUROBINDO PHARMA

Key facts

Drug name ESZOPICLONE
Active ingredients ESZOPICLONE
Application type ANDA
Application number 208451
Company AUROBINDO PHARMA
Dosage forms TABLET, ORAL
Strength 1MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Sep 15, 2016

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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