Colgate Total

   
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Colgate Total


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

Dosage - PASTE; DENTAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Sodium Fluoride; Triclosan
Multiple ingredients are in alphabetical order.

Strength - 0.24%;0.3%
The potency of the active ingredient(s), Sodium Fluoride; Triclosan. May repeat for multiple part products.

Applicant - COLGATE PALMOLIVE
The firm name holding legal responsibility for Colgate Total. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020231
The FDA assigned number to Colgate Total. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Colgate Total. 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 - Jul 11, 1997
The date Colgate Total 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 Colgate Total. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Colgate Total is in. Format is RX, OTC, DISCN.

Applicant Full Name - Colgate Palmolive
The full name of the firm holding legal responsibility for the new application of Colgate Total.

Colgate Total