Nicotine Polacrilex (orange)

   
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Nicotine Polacrilex (orange)


Drug - Nicotine Polacrilex (orange)
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 2MG BASE
The potency of the active ingredient(s), Nicotine Polacrilex. May repeat for multiple part products.

Applicant - PERRIGO
The firm name holding legal responsibility for Nicotine Polacrilex (orange). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076776
The FDA assigned number to Nicotine Polacrilex (orange). Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nicotine Polacrilex (orange). 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 - Sep 16, 2004
The date Nicotine Polacrilex (orange) 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 Nicotine Polacrilex (orange). 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 Nicotine Polacrilex (orange) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Perrigo Co
The full name of the firm holding legal responsibility for the new application of Nicotine Polacrilex (orange).

Nicotine Polacrilex (orange)