Drug application

OLANZAPINE (OLANZAPINE)

Drugs@FDA ANDA 090798 · APOTEX INC

Key facts

Drug name OLANZAPINE
Active ingredients OLANZAPINE
Application type ANDA
Application number 090798
Company APOTEX INC
Dosage forms TABLET, ORAL
Strength 2.5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Apr 23, 2012

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes 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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