first edition (1980) of the Orange Book - FDA Law Blog

II. LISTINGSA. FORMAT GUIDEThis p..tblicatioo contains the Drug Product List, three other lists orindices which facilitate its use, and an appendix, all of which aredescr ibed belCM.1. Drug Product ListThe Drug Product List contains product identification information(dosage forms, routes of administration, trade or generic names, applicationholders, strengths) for single and multiple ingredient drugproducts arranged alphabetically by active ingredient.Product informatioo for multiple ingredient products is listedalphabetically under the first active ingredient. For example,Lidocaine Hydrochloride with Epinephrine appears under Epinephrine;Lidocaine Hydrochlor ide. A cross-reference to the product informationappears for each additional active ingredient in the product.If a product is multisource, a therapeutic equivalence code willappear in front of the applicatioo holder's name. If a product istherapeutically equivalent to one or more competing products or to anappropriate standard, it will be designated with a therapeutic equi valencecode beginning with "A", and the entry will be underlined andprinted in bold foot.To improve readability, standardized terms are used to designatedosage forms, routes of administration, and strengths. In sane cases,the standardized terms used may differ from label wording.Available strengths of a dosage form are separated by asterisks.For combinatioo products, the ingredient strengths of a product areseparated by semicolons and appear in the same relative sequence as dothe ingredients in the heading.To use the Drug Product List, determine the ingredient under whichthe product informatioo is listed, using the Trade Name Index if appropriate.Then, find the ingredient in the Drug Product List. Proceed tothe dosage form; route (s) of administratim and compare products wi thinthat heading mly. Therapeutic equivalence or inequivalence is determined01 the basis of the therapeutic equivalence codes (highlighted by