Drug application

MIRTAZAPINE (MIRTAZAPINE)

Drugs@FDA ANDA 077376 · AUROBINDO PHARMA

Key facts

Drug name MIRTAZAPINE
Active ingredients MIRTAZAPINE
Application type ANDA
Application number 077376
Company AUROBINDO PHARMA
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength 15MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Labeling
Latest submission status date Feb 28, 2006

At a glance

  • 1–9 Submissions
  • 10–99 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 · Source date:

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