Dialyte W/ Dextrose 4.25% In Plastic Container

   
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Dialyte W/ Dextrose 4.25% In Plastic Container


Drug - Dialyte W/ Dextrose 4.25% In Plastic Container
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; INTRAPERITONEAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride
Multiple ingredients are in alphabetical order.

Strength - 29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML
The potency of the active ingredient(s), Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride. May repeat for multiple part products.

Applicant - B BRAUN
The firm name holding legal responsibility for Dialyte W/ Dextrose 4.25% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018460
The FDA assigned number to Dialyte W/ Dextrose 4.25% In Plastic Container. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Dialyte W/ Dextrose 4.25% In Plastic Container. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Dialyte W/ Dextrose 4.25% In Plastic Container was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Dialyte W/ Dextrose 4.25% In Plastic Container. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Dialyte W/ Dextrose 4.25% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - B Braun Medical Inc
The full name of the firm holding legal responsibility for the new application of Dialyte W/ Dextrose 4.25% In Plastic Container.

Dialyte W/ Dextrose 4.25% In Plastic Container


Isolyte E In Dextrose 5% In Plastic Container 35mg/100ml;5gm/100ml;30mg/100ml;74mg/100ml;640mg/100ml;500mg/100ml;74mg/100ml Injectable; Injection
Isolyte E W/ Dextrose 5% In Plastic Container 35mg/100ml;5gm/100ml;30mg/100ml;74mg/100ml;640mg/100ml;500mg/100ml;74mg/100ml Injectable; Injection
Plasma-lyte M And Dextrose 5% In Plastic Container 37mg/100ml;5gm/100ml;30mg/100ml;119mg/100ml;161mg/100ml;94mg/100ml;138mg/100ml Injectable; Injection
Dialyte Concentrate W/ Dextrose 30% In Plastic Container 510mg/100ml;30gm/100ml;200mg/100ml;9.2gm/100ml;9.6gm/100ml Solution; Intraperitoneal
Dialyte Concentrate W/ Dextrose 30% In Plastic Container 510mg/100ml;30gm/100ml;200mg/100ml;9.4gm/100ml;11gm/100ml Solution; Intraperitoneal
Dialyte Concentrate W/ Dextrose 50% In Plastic Container 510mg/100ml;50gm/100ml;200mg/100ml;9.2gm/100ml;9.6gm/100ml Solution; Intraperitoneal
Dialyte Concentrate W/ Dextrose 50% In Plastic Container 510mg/100ml;50gm/100ml;200mg/100ml;9.4gm/100ml;11gm/100ml Solution; Intraperitoneal
Dialyte Lm/ Dextrose 2.5% In Plastic Container 29mg/100ml;2.5gm/100ml;15mg/100ml;610mg/100ml;560mg/100ml Solution; Intraperitoneal
Dialyte W/ Dextrose 1.5% In Plastic Container 29mg/100ml;1.5gm/100ml;15mg/100ml;610mg/100ml;560mg/100ml Solution; Intraperitoneal
Dialyte W/ Dextrose 4.25% In Plastic Container 29mg/100ml;4.25gm/100ml;15mg/100ml;610mg/100ml;560mg/100ml Solution; Intraperitoneal

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