Product Information on Dextrose 5% And Potassium Chloride 0.075% In Plastic Container 5GM/100ML;75MG/100ML

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

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

Strength - 5GM/100ML;75MG/100ML
The potency of the active ingredient(s), Dextrose; Potassium Chloride. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Dextrose 5% And Potassium Chloride 0.075% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017634
The FDA assigned number to Dextrose 5% And Potassium Chloride 0.075% In Plastic Container. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Dextrose 5% And Potassium Chloride 0.075% In Plastic Container. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Dextrose 5% And Potassium Chloride 0.075% 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 Dextrose 5% And Potassium Chloride 0.075% 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 Dextrose 5% And Potassium Chloride 0.075% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Dextrose 5% And Potassium Chloride 0.075% In Plastic Container.

Dextrose 5% And Potassium Chloride 0.075% In Plastic Container

NewDrugInformation