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FDA ANDA · ANDA078446

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

sodium chloride and potassium chloride

Sponsor: OTSUKA ICU MEDCL

APPLICATION
ANDA078446
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-10
LATEST ACTION
2023-05-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION

Approval history

2023-05-15Labeling · Supplement 8 · standardAP
2008-09-10OriginalAP
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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