Delflex-lm W/ Dextrose 2.5% In Plastic Container

   
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Delflex-lm W/ Dextrose 2.5% In Plastic Container


Drug - Delflex-lm W/ Dextrose 2.5% 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;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
The potency of the active ingredient(s), Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate. May repeat for multiple part products.

Applicant - FRESENIUS MEDCL
The firm name holding legal responsibility for Delflex-lm W/ Dextrose 2.5% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018379
The FDA assigned number to Delflex-lm W/ Dextrose 2.5% In Plastic Container. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Delflex-lm W/ Dextrose 2.5% 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 - Jul 7, 1982
The date Delflex-lm W/ Dextrose 2.5% 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 Delflex-lm W/ Dextrose 2.5% 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 Delflex-lm W/ Dextrose 2.5% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Fresenius Medical Care North America
The full name of the firm holding legal responsibility for the new application of Delflex-lm W/ Dextrose 2.5% In Plastic Container.

Delflex-lm W/ Dextrose 2.5% In Plastic Container


Delflex W/ Dextrose 4.25% In Plastic Container 25.7mg/100ml;4.25gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container 25.7mg/100ml;4.25gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container 18.4mg/100ml;4.25gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal
Delflex-lm W/ Dextrose 1.5% In Plastic Container 25.7mg/100ml;1.5gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal
Delflex-lm W/ Dextrose 2.5% In Plastic Container 25.7mg/100ml;2.5gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 2.5% In Plastic Container 25.7mg/100ml;2.5gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container 25.7mg/100ml;2.5gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 2.5% Low Magnesium Low Calcium In Plastic Container 18.4mg/100ml;2.5gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 3.5% In Plastic Container 25.7mg/100ml;3.5gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal
Delflex W/ Dextrose 4.25% In Plastic Container 25.7mg/100ml;4.25gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal

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