← FDA Drug Approvals (Drugs@FDA)

RIFAXIMIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABORATORIES LIMITED · Approved 2026-03-20

Drug application

FDA Application #

ANDA220451

Application type

Abbreviated New Drug Application (Generic)

Brand name

RIFAXIMIN

Generic name

Rifaximin

Active ingredients

RIFAXIMIN

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

ALKEM LABORATORIES LIMITED

First approval

2026-03-20

Source

Authoritative

Drugs@FDA application overview

Machine

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