FDA NDA · NDA219456

CALREZDY

Sponsor: FRESENIUS MEDCL CARE

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APPLICATION
NDA219456
TYPE
NDA
ORIGINAL APPROVAL
2026-10-19
LATEST ACTION
2026-10-19
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CALREZDYPrescription
CALCUIM CHLORIDE 14.7G/L calcium chloride dihydrate (100MMOL/L calcium) · SOLUTION · INJECTION

Approval history

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