Drug application

RIFAXIMIN (RIFAXIMIN)

Drugs@FDA ANDA 208959 · ACTAVIS LABS FL INC

Key facts

Drug name RIFAXIMIN
Active ingredients RIFAXIMIN
Application type ANDA
Application number 208959
Company ACTAVIS LABS FL INC
Dosage forms TABLET, ORAL
Strength 550MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 19, 2026

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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