Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213523

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POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;74.5MG/100ML;450MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;74.5MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213523
Product Number: 001
Approval Date: Mar 9, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;149MG/100ML;450MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;149MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213523
Product Number: 005
Approval Date: Oct 11, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;149MG/100ML;450MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;149MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213523
Product Number: 002
Approval Date: Mar 9, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;224MG/100ML;450MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;224MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213523
Product Number: 003
Approval Date: Mar 9, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;298MG/100ML;450MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;298MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213523
Product Number: 004
Approval Date: Mar 9, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information