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Generic vs. Brand Name Drugs

Federal law requires that companies seeking approval for generic versions of approved drugs must prove that their generic products are the same as the original brand name drug in terms of

  • active ingredients
  • strength
  • dosage form
  • route of administration
  • labeling

The company must demonstrate that the generic form is absorbed and distributed at similar levels to the brand name drug, and all new or generic drugs must be manufactured under controlled conditions that assure product quality.

FDA firmly believes that generic drug products that have gone through the approval process can be used with the full expectation that consumers will receive the same benefits from generics as they do from brand name equivalents.