Abreva

   
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Abreva


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

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

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

Strength - 10%
The potency of the active ingredient(s), Docosanol. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020941
The FDA assigned number to Abreva. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Abreva. 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 25, 2000
The date Abreva 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 Abreva. 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 Abreva is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Abreva.

Abreva