Drug application

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE, OLANZAPINE)

Drugs@FDA ANDA 202074 · TEVA PHARMS

Key facts

Drug name OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Active ingredients FLUOXETINE HYDROCHLORIDE, OLANZAPINE
Application type ANDA
Application number 202074
Company TEVA PHARMS
Dosage forms CAPSULE, ORAL
Strength EQ 25MG BASE;EQ 3MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Mar 25, 2013

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

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