FDA NDA · NDA219455

CIENBY

Sponsor: FRESENIUS MEDCL CARE

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APPLICATION
NDA219455
TYPE
NDA
ORIGINAL APPROVAL
2026-10-19
LATEST ACTION
2026-10-19
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CIENBYPrescription
SODIUM CTIRATE 40G/L trisodium citrate dihydrate (136MMOL/L citrate) · SOLUTION · INJECTION

Approval history

2026-10-19Type 2 - New Active Ingredient · Original · standard — Label ↗AP