Chlorhexidine Gluconate

   
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Chlorhexidine Gluconate


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

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

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

Strength - 0.12%
The potency of the active ingredient(s), Chlorhexidine Gluconate. May repeat for multiple part products.

Applicant - NOVEX
The firm name holding legal responsibility for Chlorhexidine Gluconate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075561
The FDA assigned number to Chlorhexidine Gluconate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Chlorhexidine Gluconate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Nov 14, 2000
The date Chlorhexidine Gluconate 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 Chlorhexidine Gluconate. 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 Chlorhexidine Gluconate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novex Pharma
The full name of the firm holding legal responsibility for the new application of Chlorhexidine Gluconate.

Chlorhexidine Gluconate