Dianeal 137 W/ Dextrose 1.5% In Plastic Container

   
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Dianeal 137 W/ Dextrose 1.5% In Plastic Container


Drug - Dianeal 137 W/ Dextrose 1.5% 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 Chloride; Sodium Lactate
Multiple ingredients are in alphabetical order.

Strength - 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
The potency of the active ingredient(s), Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE
The firm name holding legal responsibility for Dianeal 137 W/ Dextrose 1.5% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017512
The FDA assigned number to Dianeal 137 W/ Dextrose 1.5% In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Dianeal 137 W/ Dextrose 1.5% In Plastic Container. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Dianeal 137 W/ Dextrose 1.5% 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 Dianeal 137 W/ Dextrose 1.5% In Plastic Container. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Dianeal 137 W/ Dextrose 1.5% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp
The full name of the firm holding legal responsibility for the new application of Dianeal 137 W/ Dextrose 1.5% In Plastic Container.

Dianeal 137 W/ Dextrose 1.5% In Plastic Container


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Dianeal 137 W/ Dextrose 1.5% In Plastic Container 25.7mg/100ml;1.5gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal
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Dialyte Lm/ Dextrose 1.5% In Plastic Container 26mg/100ml;1.5gm/100ml;5mg/100ml;530mg/100ml;450mg/100ml Solution; Intraperitoneal
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