Identifies drug items authorized on the basis of security & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: authorized prescription drug items with therapeutic equivalence evaluations; over the counter (OTC) drug products that need authorized applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never ever been marketed, have actually been discontinued from marketing, or that have had their approvals withdrawn for other than security or efficacy factors.
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