Sanctura

   
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Sanctura


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Trospium Chloride
Multiple ingredients are in alphabetical order.

Strength - 20MG
The potency of the active ingredient(s), Trospium Chloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021595
The FDA assigned number to Sanctura. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Sanctura. 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 - May 28, 2004
The date Sanctura 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 Sanctura. 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 Sanctura is in. Format is RX, OTC, DISCN.

Applicant Full Name - Indevus Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Sanctura.

Sanctura