← FDA Drug Approvals (Drugs@FDA)
JAKAFI XR
NDA · New Drug Application · Sponsor: INCYTE CORP · Approved 2026-05-01
Drug application
- FDA Application #
NDA217180
- Application type
- New Drug Application
- Brand name
- JAKAFI XR
- Generic name
- RUXOLITINIB
- Active ingredients
- RUXOLITINIB PHOSPHATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- INCYTE CORP
- Manufacturer
- Incyte Corporation
- First approval
- 2026-05-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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