Nicorette

   
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Nicorette


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

Dosage - GUM, CHEWING; BUCCAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 4MG BASE
The potency of the active ingredient(s), Nicotine Polacrilex. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020066
The FDA assigned number to Nicorette. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Nicorette. 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 - Feb 9, 1996
The date Nicorette 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 Nicorette. 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 Nicorette 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 Nicorette.

Nicorette