← FDA Drug Approvals (Drugs@FDA)
Ruxolitinib
NDA · New Drug Application · Sponsor: APOTEX · Approved 2025-11-21
Drug application
- FDA Application #
NDA219660- Application type
- New Drug Application
- Brand name
- Ruxolitinib
- Generic name
- Ruxolitinib
- Active ingredients
- Ruxolitinib
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- APOTEX
- First approval
- 2025-11-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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