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FDA ANDA · ANDA219619

CALCIUM GLUCONATE IN SODIUM CHLORIDE

Sponsor: SAGENT

APPLICATION
ANDA219619
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-30
LATEST ACTION
2025-12-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CALCIUM GLUCONATE IN SODIUM CHLORIDEPrescription
CALCIUM GLUCONATE 1GM/50ML (20MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE IN SODIUM CHLORIDEPrescription
CALCIUM GLUCONATE 2GM/100ML (20MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-12-30UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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