Chloraprep One-step

   
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Chloraprep One-step


Drug - Chloraprep One-step
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; Isopropyl Alcohol
Multiple ingredients are in alphabetical order.

Strength - 2%;70% (3ML)
The potency of the active ingredient(s), Chlorhexidine Gluconate; Isopropyl Alcohol. May repeat for multiple part products.

Applicant - MEDI FLEX INC
The firm name holding legal responsibility for Chloraprep One-step. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020832
The FDA assigned number to Chloraprep One-step. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Chloraprep One-step. 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 14, 2000
The date Chloraprep One-step 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 Chloraprep One-step. 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 Chloraprep One-step is in. Format is RX, OTC, DISCN.

Applicant Full Name - Medi Flex Hosp Products Inc
The full name of the firm holding legal responsibility for the new application of Chloraprep One-step.

Chloraprep One-step