Hibiclens

   
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Hibiclens


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

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

Active Ingredient(s) - Chlorhexidine Gluconate
Multiple ingredients are in alphabetical order.

Strength - 4%
The potency of the active ingredient(s), Chlorhexidine Gluconate. May repeat for multiple part products.

Applicant - REGENT
The firm name holding legal responsibility for Hibiclens. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018423
The FDA assigned number to Hibiclens. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hibiclens. 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 Hibiclens 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 Hibiclens. 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 Hibiclens is in. Format is RX, OTC, DISCN.

Applicant Full Name - Regent Medical Americas Llc
The full name of the firm holding legal responsibility for the new application of Hibiclens.

Hibiclens