Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212348

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POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;149MG/100ML;225MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;149MG/100ML;225MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212348
Product Number: 001
Approval Date: Jul 30, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER (DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE)
5GM/100ML;149MG/100ML;225MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;149MG/100ML;225MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212348
Product Number: 002
Approval Date: Jul 30, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information