← FDA Drug Approvals (Drugs@FDA)

TOFACITINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BRECKENRIDGE PHARMS · Approved 2026-02-19

Drug application

FDA Application #

ANDA209633

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOFACITINIB

Generic name

Tofacitinib

Active ingredients

TOFACITINIB

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

BRECKENRIDGE PHARMS

First approval

2026-02-19

Source

Authoritative

Drugs@FDA application overview

Machine

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