Assyro AI

Orange Book product · Generic (ANDA)

RIFAXIMIN

RIFAXIMIN

Generic (ANDA)ANDA 208959TE ABRX ACTAVIS LABS FL INC

At a glance

Mar 19, 2026

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 19, 2026

    3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

RIFAXIMIN

Strength

550MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 208959

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of RIFAXIMIN

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.