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

The product dosage form and route separated by a semi-colon.

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

Strength - 125MG
The potency of the active ingredient(s), Bosentan. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021290
The FDA assigned number to Tracleer. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Tracleer. 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 - Nov 20, 2001
The date Tracleer 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 Tracleer. 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 Tracleer is in. Format is RX, OTC, DISCN.

Applicant Full Name - Actelion Ltd
The full name of the firm holding legal responsibility for the new application of Tracleer.