Drug application

ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 079022 · TEVA PHARMS USA

Key facts

Drug name ATOMOXETINE HYDROCHLORIDE
Active ingredients ATOMOXETINE HYDROCHLORIDE
Application type ANDA
Application number 079022
Company TEVA PHARMS USA
Dosage forms CAPSULE, ORAL
Strength EQ 10MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 30, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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:

Browse all Drugs@FDA applications