Issued to CHIESI. Application is approved as submitted.
Issued
March 31, 2026Application
NDA 505b1 • 019734
Product
CARDENE / CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER / CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
Company
CHIESI
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for CARDENE, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER on 2026-03-31. The source metadata identifies NDA 019734 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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This letter documents an FDA approval action: FDA approved NDA 019734 for CARDENE / CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER / CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, sponsored by CHIESI, on March 31, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 019734 is the application under which FDA issued this approval letter for CARDENE / CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER / CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER to CHIESI. The letter is dated March 31, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.