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FDA ANDA · ANDA212348

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE

dextrose monohydrate, sodium chloride, and potassium chloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA212348
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-30
LATEST ACTION
2021-07-30
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 225MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 225MG/100ML · INJECTABLE · INJECTION

Approval history

2021-07-30UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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