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FDA ANDA · ANDA214623
CARDIOPLEGIC SOLUTION
potassium chloride, sodium chloride, calcium chloride, and magnesium chloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA214623
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-18
LATEST ACTION
2022-02-18
ROUTE
INTRA-ARTERIAL, PERFUSION, CARDIAC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CARDIOPLEGIC IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 17.6MG/100ML, MAGNESIUM CHLORIDE 325.3MG/100ML, POTASSIUM CHLORIDE 119.3MG/100ML, SODIUM CHLORIDE 643MG/100ML · SOLUTION · PERFUSION, CARDIAC
Approval history
2022-02-18UNKNOWN · 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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