Drug application

FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE)

Drugs@FDA NDA 204168 · ABBVIE

Key facts

Drug name FETZIMA
Active ingredients LEVOMILNACIPRAN HYDROCHLORIDE
Application type NDA
Application number 204168
Company ABBVIE
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength EQ 20MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Jul 25, 2013

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 1–9 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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