← FDA DRUG APPROVALS

FDA ANDA · ANDA211428

POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE

potassium chloride, sodium chloride, calcium chloride, sodium lactate, and dextrose monohydrate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA211428
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-09
LATEST ACTION
2021-11-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 179MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION

Approval history

2021-11-09UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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