Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020163

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DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
25.7MG/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: DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AT
Application Number: N020163
Product Number: 001
Approval Date: Dec 4, 1992
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
25.7MG/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: DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AT
Application Number: N020163
Product Number: 002
Approval Date: Dec 4, 1992
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
25.7MG/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: DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AT
Application Number: N020163
Product Number: 003
Approval Date: Dec 4, 1992
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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