← FDA Drug Approvals (Drugs@FDA)

TOFACITINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPECGX LLC · Approved 2026-03-06

Drug application

FDA Application #

ANDA219395

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOFACITINIB

Generic name

Tofacitinib Citrate

Active ingredients

TOFACITINIB CITRATE

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

SPECGX LLC

First approval

2026-03-06

Source

Authoritative

Drugs@FDA application overview

Machine

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