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Product Details for NDA 020171

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DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Marketing Status: Prescription
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N020171
Product Number: 001
Approval Date: Aug 19, 1992
Applicant Holder Full Name: FRESENIUS MEDICAL CARE NORTH AMERICA
Marketing Status:  Prescription
Patent and Exclusivity Information
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Marketing Status: Prescription
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N020171
Product Number: 002
Approval Date: Aug 19, 1992
Applicant Holder Full Name: FRESENIUS MEDICAL CARE NORTH AMERICA
Marketing Status:  Prescription
Patent and Exclusivity Information
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Marketing Status: Prescription
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N020171
Product Number: 003
Approval Date: Aug 19, 1992
Applicant Holder Full Name: FRESENIUS MEDICAL CARE NORTH AMERICA
Marketing Status:  Prescription
Patent and Exclusivity Information
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