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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216274

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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: No
Reference Standard: No
TE Code: AP
Application Number: A216274
Product Number: 001
Approval Date: Oct 2, 2023
Applicant Holder Full Name: AMERICAN REGENT INC
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: No
Reference Standard: No
TE Code: AP
Application Number: A216274
Product Number: 002
Approval Date: Oct 2, 2023
Applicant Holder Full Name: AMERICAN REGENT INC
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: No
Reference Standard: No
TE Code: AP
Application Number: A216274
Product Number: 003
Approval Date: Oct 2, 2023
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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