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RUXOLITINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2026-06-09

Drug application

FDA Application #

ANDA208869

Application type

Abbreviated New Drug Application (Generic)

Brand name

RUXOLITINIB

Generic name

Ruxolitinib

Active ingredients

RUXOLITINIB

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

APOTEX INC

First approval

2026-06-09

Source

Authoritative

Drugs@FDA application overview

Machine

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