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TOFACITINIB CITRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SINOTHERAPEUTICS INC · Approved 2025-09-30

Drug application

FDA Application #
ANDA216001
Application type
Abbreviated New Drug Application (Generic)
Brand name
TOFACITINIB CITRATE
Generic name
Tofacitinib Citrate
Active ingredients
TOFACITINIB CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
SINOTHERAPEUTICS INC
First approval
2025-09-30

Source

Authoritative
Drugs@FDA application overview
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