Drug application

DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 204815 · MACLEODS PHARMS

Key facts

Drug name DULOXETINE HYDROCHLORIDE
Active ingredients DULOXETINE HYDROCHLORIDE
Application type ANDA
Application number 204815
Company MACLEODS PHARMS
Dosage forms CAPSULE, DELAYED REL PELLETS, ORAL
Strength EQ 20MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 23, 2017

At a glance

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