Tilde (~) delimited Orange Book approved products:
Ingredient
The active ingredient(s) for the product. Multiple
ingredients are in alphabetical order separated by a semicolon.
Dosage form;Route of Administration
Trade Name
Applicant
The firm name holding legal responsibility for the new drug
application. The firm name is condensed to a maximum twenty character unique string.
Strength
New Drug Application (NDA) Number
Product Number
The FDA assigned number to identify the application
products. Each strength is a separate product. May repeat for multiple part
products. Format is nnn.
Therapeutic Equivalence (TE) Code
Approval Date
The date the product 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)
The pioneer or innovator of the drug. The RLD identifies
the product Abbreviated New Drug Applications (ANDA) use as a reference.
Format is Yes or
No.
Type
The group or category of approved drugs. Format is RX, OTC, DISCN.
Applicant Full Name