Isolyte R W/ Dextrose 5% In Plastic Container

   
Google
 
Web NewDrugInformation.com

Isolyte R W/ Dextrose 5% In Plastic Container


Drug - Isolyte R W/ Dextrose 5% In Plastic Container
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - 37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/100ML
The potency of the active ingredient(s), Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride. May repeat for multiple part products.

Applicant - B BRAUN
The firm name holding legal responsibility for Isolyte R W/ Dextrose 5% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018271
The FDA assigned number to Isolyte R W/ Dextrose 5% In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Isolyte R W/ Dextrose 5% 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 Isolyte R W/ Dextrose 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 Isolyte R W/ Dextrose 5% 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 Isolyte R W/ Dextrose 5% 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 Isolyte R W/ Dextrose 5% In Plastic Container.

Isolyte R W/ Dextrose 5% In Plastic Container


Phoslo Eq 84.5mg Calcium Capsule; Oral
Phoslo Gelcaps Eq 169mg Calcium Capsule; Oral
Phoslo Eq 169mg Calcium Tablet; Oral
Pepcid Complete 800mg;10mg;165mg Tablet, Chewable; Oral
Actonel With Calcium (copackaged) Eq 500mg Base,n/a;n/a,35mg Tablet, Tablet; Oral
Calcium Chloride 10% In Plastic Container 100mg/ml Injectable; Injection
Bss Plus 0.154mg/ml;0.92mg/ml;0.184mg/ml;0.2mg/ml;0.38mg/ml;2.1mg/ml;7.14mg/ml;0.42mg/ml Solution; Irrigation
Endosol Extra 0.154mg/ml;0.92mg/ml;0.184mg/ml;0.2mg/ml;0.38mg/ml;2.1mg/ml;7.14mg/ml;0.42mg/ml Solution; Irrigation
Isolyte R In Dextrose 5% In Plastic Container 37mg/100ml;5gm/100ml;31mg/100ml;120mg/100ml;330mg/100ml;88mg/100ml Injectable; Injection
Isolyte R W/ Dextrose 5% In Plastic Container 37mg/100ml;5gm/100ml;31mg/100ml;120mg/100ml;330mg/100ml;88mg/100ml Injectable; Injection

NewDrugInformation