Pre-op Ii

   
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Pre-op Ii


Drug - Pre-op Ii
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) - Hexachlorophene
Multiple ingredients are in alphabetical order.

Strength - 480MG
The potency of the active ingredient(s), Hexachlorophene. May repeat for multiple part products.

Applicant - DAVIS AND GECK
The firm name holding legal responsibility for Pre-op Ii. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017433
The FDA assigned number to Pre-op Ii. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pre-op Ii. 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 - Approved Prior to Jan 1, 1982
The date Pre-op Ii 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 Pre-op Ii. 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 Pre-op Ii is in. Format is RX, OTC, DISCN.

Applicant Full Name - Davis And Geck Div American Cyanamid Co
The full name of the firm holding legal responsibility for the new application of Pre-op Ii.

Pre-op Ii