Drug application

DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 090669 · IMPAX LABS INC

Key facts

Drug name DULOXETINE HYDROCHLORIDE
Active ingredients DULOXETINE HYDROCHLORIDE
Application type ANDA
Application number 090669
Company IMPAX LABS INC
Dosage forms CAPSULE, DELAYED RELEASE, ORAL
Strength EQ 20MG BASE
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Nov 18, 2010

At a glance

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

Browse all Drugs@FDA applications