← FDA Drug Approvals (Drugs@FDA)

TOFACITINIB CITRATE

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

Drug application

FDA Application #

ANDA218900

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOFACITINIB CITRATE

Generic name

Tofacitinib Citrate

Active ingredients

TOFACITINIB CITRATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

SAPTALIS PHARMS

First approval

2026-06-09

Source

Authoritative

Drugs@FDA application overview

Machine

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