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UPADACITINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ INC · Approved 2025-11-14

Drug application

FDA Application #
ANDA218792
Application type
Abbreviated New Drug Application (Generic)
Brand name
UPADACITINIB
Generic name
Upadacitinib
Active ingredients
UPADACITINIB
Dosage form
TABLET, EXTENDED RELEASE
Route
—
Marketing status
None (Tentative Approval)
Sponsor
SANDOZ INC
First approval
2025-11-14

Source

Authoritative
Drugs@FDA application overview
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