Virac Rex

   
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Virac Rex


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

Dosage - SOLUTION; TOPICAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Undecoylium Chloride; Undecoylium Chloride Iodine Complex
Multiple ingredients are in alphabetical order.

Strength - 0.5%;1.8%
The potency of the active ingredient(s), Undecoylium Chloride; Undecoylium Chloride Iodine Complex. May repeat for multiple part products.

Applicant - CHESEBROUGH PONDS
The firm name holding legal responsibility for Virac Rex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 011914
The FDA assigned number to Virac Rex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Virac Rex. 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 - Approved Prior to Jan 1, 1982
The date Virac Rex 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 Virac Rex. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Chesebrough Ponds Inc
The full name of the firm holding legal responsibility for the new application of Virac Rex.

Virac Rex