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• 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
  • labeling (to some extent)
  • scoring
  • excipients (including colors, flavors, preservatives)
  FDA - Cite This Source - This Definition
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  Cite Definition for Pharmaceutical Equivalents

  American Psychological Association (APA)

  Pharmaceutical Equivalents. (n.d.). [email protected] Glossary of Terms. Retrieved January 29, 2023, from website: http://www.expertglossary.com/definition/pharmaceutical-equivalents.

  Chicago Manual of Style (CMS)

  Pharmaceutical Equivalents. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/pharmaceutical-equivalents (accessed: January 29, 2023).

  Modern Language Association (MLA)

  "Pharmaceutical Equivalents." [email protected] Glossary of Terms. FDA. 29 January. 2023 http://www.expertglossary.com/definition/pharmaceutical-equivalents.

• Browse Related Terms: Brand Name Drug, Chemical Type, Dosage Form, Drug Product, Generic Drug, Medication Guide, New Molecular Entity (NME), Over-the-Counter Drugs (OTC), Patient Package Insert (PPI), Pharmaceutical Equivalents, Prescription Drug Product, Strength, Therapeutic Equivalence (TE), Therapeutic Equivalence (TE) Codes