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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

2024-07-26Type 5 - New Formulation or New Manufacturer · 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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