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Pharmaceutical equivalents

FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:

  • they contain the same active ingredient(s)
  • they are of the same dosage form and route of administration
  • they are identical in strength or concentration
Pharmaceutically equivalent drug products may differ in characteristics such as

  • shape
  • release mechanism
  • labelling (to some extent)
  • scoring
  • excipients (including colors, flavors, preservatives)
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