Sps

   
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Sps


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

Dosage - SUSPENSION; 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 - 15GM/60ML
The potency of the active ingredient(s), Sodium Polystyrene Sulfonate. May repeat for multiple part products.

Applicant - CAROLINA MEDCL
The firm name holding legal responsibility for Sps. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087859
The FDA assigned number to Sps. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Sps. 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 - Dec 8, 1982
The date Sps 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 Sps. 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 Sps is in. Format is RX, OTC, DISCN.

Applicant Full Name - Carolina Medical Products Co
The full name of the firm holding legal responsibility for the new application of Sps.

Sps