← FDA Drug Approvals (Drugs@FDA)
ENSACOVE
NDA · New Drug Application · Sponsor: XCOVERY · Approved 2024-12-18
Drug application
- FDA Application #
NDA218171
- Application type
- New Drug Application
- Brand name
- ENSACOVE
- Generic name
- ENSARTINIB
- Active ingredients
- ENSARTINIB HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- XCOVERY
- Manufacturer
- Xcovery Holdings, Inc.
- First approval
- 2024-12-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown