APPLICATION
ANDA214805
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-04
LATEST ACTION
2024-01-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM ACETATEPrescription
SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATEPrescription
SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATEPrescription
SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATEPrescription
SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
Approval history
2024-01-22Manufacturing (CMC) · Supplement 5 · unknownAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.