Drug application

CYMBALTA (DULOXETINE HYDROCHLORIDE)

Drugs@FDA NDA 021427 · LILLY

Key facts

Drug name CYMBALTA
Active ingredients DULOXETINE HYDROCHLORIDE
Application type NDA
Application number 021427
Company LILLY
Dosage forms CAPSULE, DELAYED REL PELLETS, ORAL
Strength EQ 20MG BASE
Marketing status Discontinued
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Aug 3, 2004

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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