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Key Points
Audio Transcript
Remember, an Abbreviated New Drug Application contains data that provide for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product.
The primary requirement for a drug to be eligible to get approval based on an ANDA is that the drug has to have the same active ingredient or ingredients, route of administration, dosage form, strength, and conditions of use as a drug that FDA has already approved, or a "reference listed drug" (RLD).
Every generic product must have a listed reference drug. When we approve generic products, we rely on the findings of safety and efficacy for the particular reference drug as part of the basis for approving a generic drug.