Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018460

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DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE)
29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
Proprietary Name: DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 006
Approval Date: Jan 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE)
29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
Proprietary Name: DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE)
29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
Proprietary Name: DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 007
Approval Date: Jan 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 005
Approval Date: Nov 2, 1983
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 008
Approval Date: Jan 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 009
Approval Date: Jan 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER (CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE)
26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML
Marketing Status: Discontinued

Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Proprietary Name: DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAPERITONEAL
Strength: 26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018460
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information