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A: An Authorized Generic is a brand-name prescription drugâalready approved as a New Drug Application (NDA) by the FDA âand marketed as a generic under a private label. The Authorized Generic is sold and distributed as a generic product by the private label company. It has the identical size, shape, color, taste, smell, mouth feel, active ingredients and unlike a generic, the Authorized Generic has the identical inactive ingredients.
âTraditionalâ generic drugs are copies that one company makes of a brand-name drug that another company developed. They are the same as the brand name drug in active ingredient, dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.