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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218343

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE (POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC)
1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)
Marketing Status: Prescription
Active Ingredient: POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Proprietary Name: POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218343
Product Number: 001
Approval Date: Jul 26, 2024
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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