FDA NDA · NDA221033
YULZETY
Sponsor: ROSEMONT PHARMS
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APPLICATION
NDA221033
TYPE
NDA
ORIGINAL APPROVAL
2026-10-16
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
YULZETYPrescription
RIVAROXABAN 4MG/ML · SUSPENSION · ORAL
YULZETYPrescription
RIVAROXABAN 2MG/ML · SUSPENSION · ORAL
Approval history
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →