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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019513

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS)
5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML
Marketing Status: Prescription
Active Ingredient: DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
Proprietary Name: IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019513
Product Number: 001
Approval Date: May 8, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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