Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212346

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DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% (DEXTROSE; POTASSIUM CHLORIDE)
5GM/100ML;75MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE
Proprietary Name: DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;75MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212346
Product Number: 001
Approval Date: Sep 10, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% (DEXTROSE; POTASSIUM CHLORIDE)
5GM/100ML;150MG/100ML
Marketing Status: Prescription

Active Ingredient: DEXTROSE; POTASSIUM CHLORIDE
Proprietary Name: DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;150MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212346
Product Number: 002
Approval Date: Sep 10, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information