Drug application

MIRTAZAPINE (MIRTAZAPINE)

Drugs@FDA ANDA 076921 · AUROBINDO

Key facts

Drug name MIRTAZAPINE
Active ingredients MIRTAZAPINE
Application type ANDA
Application number 076921
Company AUROBINDO
Dosage forms TABLET, ORAL
Strength 7.5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Oct 22, 2004

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No FDA letters on file
  • No FDA reviews on file

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 · Source date:

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