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FDA NDA · NDA218343
POTASSIUM PHOSPHATES
potassium phosphates in sodium chloride
Sponsor: AMNEAL
APPLICATION
NDA218343
TYPE
NDA
ORIGINAL APPROVAL
2024-07-26
LATEST ACTION
2024-07-26
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE · ReferencePrescription
POTASSIUM PHOSPHATE, DIBASIC 1.18GM/250ML (4.72MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 1.12GM/250ML (4.48MG/ML) · SOLUTION · INTRAVENOUS
Approval history
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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