Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212832

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POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC)
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)
Marketing Status: Prescription

Active Ingredient: POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Proprietary Name: POTASSIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N212832
Product Number: 001
Approval Date: Nov 26, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC)
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)
Marketing Status: Prescription

Active Ingredient: POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Proprietary Name: POTASSIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N212832
Product Number: 002
Approval Date: Nov 26, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC)
11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)
Marketing Status: Prescription

Active Ingredient: POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Proprietary Name: POTASSIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N212832
Product Number: 003
Approval Date: Nov 26, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: N212832
Product Number: 005
Approval Date: May 9, 2025
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE (POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC)
1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/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/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212832
Product Number: 004
Approval Date: May 9, 2025
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information