Drug - Tranxene
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) - Clorazepate Dipotassium
Multiple ingredients are in alphabetical order.

Strength - 15MG
The potency of the active ingredient(s), Clorazepate Dipotassium. May repeat for multiple part products.

The firm name holding legal responsibility for Tranxene. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017105
The FDA assigned number to Tranxene. Format is nnnnnn.

Product Number - 008
The FDA assigned number to identify Tranxene. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Tranxene 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 Tranxene. 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 Tranxene is in. Format is RX, OTC, DISCN.

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