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TOFACITINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LIMITED · Approved 2025-09-17

Drug application

FDA Application #

ANDA215356

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOFACITINIB

Generic name

Tofacitinib

Active ingredients

TOFACITINIB

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

AUROBINDO PHARMA LIMITED

First approval

2025-09-17

Source

Authoritative

Drugs@FDA application overview

Machine

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