← FDA Drug Approvals (Drugs@FDA)
OPZELURA
NDA · New Drug Application · Sponsor: INCYTE CORP · Approved 2021-09-21
Drug application
- FDA Application #
NDA215309
- Application type
- New Drug Application
- Brand name
- OPZELURA
- Generic name
- RUXOLITINIB
- Active ingredients
- RUXOLITINIB PHOSPHATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Marketing status
- Prescription
- Sponsor
- INCYTE CORP
- Manufacturer
- Incyte Corporation
- First approval
- 2021-09-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown