Drug - Tornalate
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) - Bitolterol Mesylate
Multiple ingredients are in alphabetical order.

Strength - 0.37MG/INH
The potency of the active ingredient(s), Bitolterol Mesylate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018770
The FDA assigned number to Tornalate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tornalate. 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 28, 1984
The date Tornalate 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) - No
The pioneer or innovator of Tornalate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Tornalate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Tornalate.