Product Details for ANDA 218314
SODIUM PHOSPHATES (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE)
1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)
Marketing Status: Prescription
4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)
Marketing Status: Prescription
13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)
Marketing Status: Prescription
1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Proprietary Name: SODIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218314
Product Number: 001
Approval Date: Jun 21, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status: Prescription
Patent and Exclusivity Information
SODIUM PHOSPHATES (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE)
Proprietary Name: SODIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218314
Product Number: 001
Approval Date: Jun 21, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status: Prescription
Patent and Exclusivity Information
4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Proprietary Name: SODIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218314
Product Number: 002
Approval Date: Jun 21, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status: Prescription
Patent and Exclusivity Information
SODIUM PHOSPHATES (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE)
Proprietary Name: SODIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218314
Product Number: 002
Approval Date: Jun 21, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status: Prescription
Patent and Exclusivity Information
13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Proprietary Name: SODIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218314
Product Number: 003
Approval Date: Jun 21, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: SODIUM PHOSPHATES
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218314
Product Number: 003
Approval Date: Jun 21, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status: Prescription
Patent and Exclusivity Information