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FDA NDA · NDA018494
LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, calcium chloride
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA018494
TYPE
NDA
ORIGINAL APPROVAL
1982-02-19
LATEST ACTION
2014-09-30
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
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 · SOLUTION · IRRIGATION
Approval history
2014-09-30Manufacturing (CMC) · Supplement 26 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 27 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 25 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 14 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 15 · standardAP
1991-11-14Manufacturing (CMC) · Supplement 11 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 12 · standardAP
1991-01-10Manufacturing (CMC) · Supplement 13 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 10 · standardAP
1986-10-30Manufacturing (CMC) · Supplement 9 · standardAP
1985-06-26Labeling · Supplement 7AP
1985-01-24Manufacturing (CMC) · Supplement 3 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 5 · standardAP
1982-05-07Manufacturing (CMC) · Supplement 1 · standardAP
1982-02-19Type 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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