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FDA ANDA · ANDA209338
LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, calcium chloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA209338
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-28
LATEST ACTION
2025-03-13
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
2025-03-13Labeling · Supplement 15 · standardAP
2019-10-22Labeling · Supplement 2 · standardAP
2019-01-28UNKNOWN · 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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