← FDA DRUG APPROVALS
FDA NDA · NDA020004
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA020004
TYPE
NDA
ORIGINAL APPROVAL
1992-04-21
LATEST ACTION
2002-07-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINERDiscontinued
SODIUM LACTATE 1.87GM/100ML · INJECTABLE · INJECTION
Approval history
2002-07-01Manufacturing (CMC) · Supplement 6 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 4 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 3 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 2 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 1 · standardAP
1992-04-21Type 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.