Drug application

DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 090783 · TEVA PHARMS USA

Key facts

Drug name DULOXETINE HYDROCHLORIDE
Active ingredients DULOXETINE HYDROCHLORIDE
Application type ANDA
Application number 090783
Company TEVA PHARMS USA
Dosage forms CAPSULE, DELAYED REL PELLETS, ORAL
Strength EQ 20MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission status date Dec 11, 2013

At a glance

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