APPLICATION
ANDA218469
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-08
LATEST ACTION
2026-03-02
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM ACETATEPrescription
SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATEPrescription
SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATEPrescription
SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
Approval history
2026-03-02Manufacturing (CMC) · Supplement 2 · unknownAP
2025-08-08UNKNOWN · Original · standardAP
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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