Trileptal

   
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Trileptal


Drug - Trileptal
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) - Oxcarbazepine
Multiple ingredients are in alphabetical order.

Strength - 600MG
The potency of the active ingredient(s), Oxcarbazepine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021014
The FDA assigned number to Trileptal. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Trileptal. 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 - Jan 14, 2000
The date Trileptal 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 Trileptal. 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 Trileptal 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 Trileptal.

Trileptal