APPLICATION
NDA018947
TYPE
NDA
ORIGINAL APPROVAL
1984-09-05
LATEST ACTION
2014-07-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SODIUM LACTATE IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM LACTATE 5MEQ/ML · INJECTABLE · INJECTION
Approval history
2014-07-15Manufacturing (CMC) · Supplement 24 · standardAP
2014-06-12Manufacturing (CMC) · Supplement 23 · standardAP
2001-08-15Labeling · Supplement 14 · standardAP
2001-02-16Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-23Labeling · Supplement 11 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 12 · standardAP
1999-03-31Manufacturing (CMC) · Supplement 13 · standardAP
1997-11-19Labeling · Supplement 10 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 8 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 9 · standardAP
1988-10-21Manufacturing (CMC) · Supplement 6 · standardAP
1987-12-11Manufacturing (CMC) · Supplement 5 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 4 · standardAP
1985-12-06Manufacturing (CMC) · Supplement 3 · standardAP
1985-08-01Manufacturing (CMC) · Supplement 1 · standardAP
1985-05-28Labeling · Supplement 2AP
1984-09-05Type 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.
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.