Visicol

   
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Visicol


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

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

Active Ingredient(s) - Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate
Multiple ingredients are in alphabetical order.

Strength - 0.398GM;1.102GM
The potency of the active ingredient(s), Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate. May repeat for multiple part products.

Applicant - SALIX PHARMS
The firm name holding legal responsibility for Visicol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021097
The FDA assigned number to Visicol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Visicol. 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 - Sep 21, 2000
The date Visicol 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 Visicol. 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 Visicol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Salix Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Visicol.

Visicol