Nicotine
Drug - Nicotine
The trade name of the product as shown on the labeling.
Dosage -
FILM, EXTENDED RELEASE; TRANSDERMAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Nicotine
Multiple ingredients are in alphabetical order.
Strength -
7MG/24HR
The potency of the active ingredient(s), Nicotine. May repeat for multiple part products.
Applicant -
SANO
The firm name holding legal responsibility for Nicotine. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074645
The FDA assigned number to Nicotine. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Nicotine. 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 20, 1997
The date Nicotine 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. 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 Nicotine is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Sano Corp
The full name of the firm holding legal responsibility for the new application of Nicotine.
Nicotine
Niclocide 500mg Tablet, Chewable; Oral Habitrol 14mg/24hr Film, Extended Release; Transdermal Habitrol 21mg/24hr Film, Extended Release; Transdermal Habitrol 7mg/24hr Film, Extended Release; Transdermal Nicoderm Cq 14mg/24hr Film, Extended Release; Transdermal Nicoderm Cq 21mg/24hr Film, Extended Release; Transdermal Nicoderm Cq 7mg/24hr Film, Extended Release; Transdermal Nicotine 14mg/24hr Film, Extended Release; Transdermal Nicotine 21mg/24hr Film, Extended Release; Transdermal Nicotine 7mg/24hr Film, Extended Release; Transdermal
NewDrugInformation
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