Prostep

   
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Prostep


Drug - Prostep
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 - 11MG/24HR
The potency of the active ingredient(s), Nicotine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019983
The FDA assigned number to Prostep. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Prostep. 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 - Dec 23, 1998
The date Prostep 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 Prostep. 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 Prostep is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aveva Drug Delivery Systems Inc
The full name of the firm holding legal responsibility for the new application of Prostep.

Prostep