← FDA Drug Approvals (Drugs@FDA)

TOFACITINIB CITRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2023-03-14

Drug application

FDA Application #

ANDA209829

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

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2023-03-14

Source

Authoritative

Drugs@FDA application overview

Machine

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