Chloraprep One-step Sepp

   
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Chloraprep One-step Sepp


Drug - Chloraprep One-step Sepp
The trade name of the product as shown on the labeling.

Dosage - SWAB; 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% (0.67ML)
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 Sepp. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021555
The FDA assigned number to Chloraprep One-step Sepp. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Chloraprep One-step Sepp. 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 - Oct 7, 2002
The date Chloraprep One-step Sepp 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 Sepp. 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 Sepp 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 Sepp.

Chloraprep One-step Sepp