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FDA ANDA · ANDA210332
LACTATED RINGERS AND DEXTROSE
sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA210332
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-28
LATEST ACTION
2022-12-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% AND LACTATED RINGER'SPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
Approval history
2022-12-22Manufacturing (CMC) · Supplement 1 · unknownAP
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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