← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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