← FDA DRUG APPROVALS
FDA NDA · NDA019632
LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, and calcium chloride
Sponsor: B BRAUN
APPLICATION
NDA019632
TYPE
NDA
ORIGINAL APPROVAL
1988-02-29
LATEST ACTION
2025-11-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
Approval history
2016-06-17Manufacturing (CMC) · Supplement 36 · standardAP
2004-08-06Labeling · Supplement 22AP
2002-07-01Manufacturing (CMC) · Supplement 21 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 19 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 18 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 17 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 15 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 12 · standardAP
1993-04-26Manufacturing (CMC) · Supplement 13 · standardAP
1992-12-29Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 9 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 8 · standardAP
1990-04-13Manufacturing (CMC) · Supplement 6 · standardAP
1989-11-22Manufacturing (CMC) · Supplement 7 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 3 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 5 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 4 · standardAP
1988-12-21Manufacturing (CMC) · Supplement 2 · standardAP
1988-03-25Labeling · Supplement 1AP
1988-02-29Type 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.