Drug application

XIFAXAN (RIFAXIMIN)

Drugs@FDA NDA 022554 · SALIX PHARMS

Key facts

Drug name XIFAXAN
Active ingredients RIFAXIMIN
Application type NDA
Application number 022554
Company SALIX PHARMS
Dosage forms TABLET, ORAL
Strength 550MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 6 - New Indication (no longer used)
Latest submission status date Mar 24, 2010

At a glance

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