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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019395

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INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE)
25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100ML
Marketing Status: Discontinued
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019395
Product Number: 001
Approval Date: Mar 26, 1986
Applicant Holder Full Name: FRESENIUS MEDICAL CARE NORTH AMERICA
Marketing Status:  Discontinued
Patent and Exclusivity Information
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE)
25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100ML
Marketing Status: Discontinued
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019395
Product Number: 002
Approval Date: Mar 26, 1986
Applicant Holder Full Name: FRESENIUS MEDICAL CARE NORTH AMERICA
Marketing Status:  Discontinued
Patent and Exclusivity Information
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE)
25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100ML
Marketing Status: Discontinued
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019395
Product Number: 003
Approval Date: Mar 26, 1986
Applicant Holder Full Name: FRESENIUS MEDICAL CARE NORTH AMERICA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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