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• The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.

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  Cite Definition for Approval History

  American Psychological Association (APA)

  Approval History. (n.d.). [email protected] Glossary of Terms. Retrieved June 9, 2023, from website: http://www.expertglossary.com/definition/approval-history.

  Chicago Manual of Style (CMS)

  Approval History. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/approval-history (accessed: June 9, 2023).

  Modern Language Association (MLA)

  "Approval History." [email protected] Glossary of Terms. FDA. 9 June. 2023 http://www.expertglossary.com/definition/approval-history.

• Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval