← FDA Drug Approvals (Drugs@FDA)

TOFACITINIB CITRATE

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

Drug application

FDA Application #

ANDA219530

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOFACITINIB CITRATE

Generic name

TOFACITINIB

Active ingredients

TOFACITINIB CITRATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MACLEODS PHARMS

Manufacturer

Macleods Pharmaceuticals Limited

First approval

2026-06-03

Source

Authoritative

Drugs@FDA application overview

Machine

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