APPLICATION
NDA018893
TYPE
NDA
ORIGINAL APPROVAL
1983-05-04
LATEST ACTION
2014-09-02
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM ACETATE · ReferencePrescription
SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATE · ReferencePrescription
SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM ACETATE · ReferencePrescription
SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) · SOLUTION · INTRAVENOUS
Approval history
2014-06-12Manufacturing (CMC) · Supplement 28 · standardAP
2001-02-16Manufacturing (CMC) · Supplement 16 · standardAP
2000-06-15Labeling · Supplement 13 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 15 · standardAP
1999-01-22Manufacturing (CMC) · Supplement 14 · standardAP
1998-05-05Labeling · Supplement 12 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 10 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1988-11-17Manufacturing (CMC) · Supplement 8 · standardAP
1987-12-11Manufacturing (CMC) · Supplement 7 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 6 · standardAP
1985-05-14Manufacturing (CMC) · Supplement 5 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 3 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 4 · standardAP
1984-01-17Manufacturing (CMC) · Supplement 2 · standardAP
1983-05-04Type 5 - New Formulation or New Manufacturer · 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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