Transderm Scop

   
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Transderm Scop


Drug - Transderm Scop
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) - Scopolamine
Multiple ingredients are in alphabetical order.

Strength - 1MG/72HR
The potency of the active ingredient(s), Scopolamine. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Transderm Scop. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017874
The FDA assigned number to Transderm Scop. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Transderm Scop. 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 - Approved Prior to Jan 1, 1982
The date Transderm Scop 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 Transderm Scop. 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 Transderm Scop is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Consumer Health Inc
The full name of the firm holding legal responsibility for the new application of Transderm Scop.

Transderm Scop