Enablex

   
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Enablex


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

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

Active Ingredient(s) - Darifenacin Hydrobromide
Multiple ingredients are in alphabetical order.

Strength - EQ 15MG BASE
The potency of the active ingredient(s), Darifenacin Hydrobromide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021513
The FDA assigned number to Enablex. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Enablex. 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 22, 2004
The date Enablex 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 Enablex. 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 Enablex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Enablex.

Enablex