Kayexalate

   
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Kayexalate


Drug - Kayexalate
The trade name of the product as shown on the labeling.

Dosage - POWDER; ORAL, RECTAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Sodium Polystyrene Sulfonate
Multiple ingredients are in alphabetical order.

Strength - 453.6GM/BOT
The potency of the active ingredient(s), Sodium Polystyrene Sulfonate. May repeat for multiple part products.

Applicant - SANOFI SYNTHELABO
The firm name holding legal responsibility for Kayexalate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 011287
The FDA assigned number to Kayexalate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Kayexalate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Kayexalate 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) - Yes
The pioneer or innovator of Kayexalate. 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 Kayexalate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Kayexalate.

Kayexalate