Issued to MILLA PHARMS. Application is approved as submitted.
Posted by FDA
September 1, 2026Application
ANDA 505j • 219037
Product
CALCIUM GLUCONATE IN SODIUM CHLORIDE
Company
MILLA PHARMS
Stage
Final Decision
Assyro regulatory brief
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FDA posted an approval letter for CALCIUM GLUCONATE IN SODIUM CHLORIDE on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219037 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved ANDA 219037 for CALCIUM GLUCONATE IN SODIUM CHLORIDE, sponsored by MILLA PHARMS,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
ANDA 219037 is the application under which FDA issued this approval letter for CALCIUM GLUCONATE IN SODIUM CHLORIDE to MILLA PHARMS. FDA posted the letter on September 1, 2026; the posting date is not the decision date.
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.