Drug application

ZYPREXA (OLANZAPINE)

Drugs@FDA NDA 020592 · CHEPLAPHARM

Key facts

Drug name ZYPREXA
Active ingredients OLANZAPINE
Application type NDA
Application number 020592
Company CHEPLAPHARM
Dosage forms TABLET, ORAL
Strength 2.5MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Sep 30, 1996

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • No FDA letters on file
  • Yes 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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