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View the FDA Review Documents for your Dosage Form

To learn more about the drug's approval and review history, you can look up your drug in the FDA Approved Drug Products Database:

Follow these steps:

  1. Look up your drug by its proprietary (brand name) in the FDA Approved Drug Products database. This database is very picky, so even if you have an extra space after your brand name, it may not find the drug. 
  2. When your drug's brand name comes up, click on the hyperlinked name
  3. Scroll past the table and click on Approval Date(s) and History, Letters, Labels, Reviews for NDA.... to expand that section

screenshot of step 3

  1. Now that you've expanded the Approval Date(s) and History, Letters, Labels, Reviews for NDA.... section, look at the available documents on the right-hand side of the table, in the column Letters, Review, Labels, Patient Package Insert, and select Review

Screenshot of step 4

  1. There will be multiple review documents. You'll likely find some of the review documents to be more helpful than others for this project. The reviews that come up may differ by your drug; however, if available, the following tend to be more useful reviews:
    • Summary Review
    • Medical Review
    • Chemistry Review
    • Pharmacology Review
    • Clinical Pharmacology Biopharmaceutics Review
    • *Other Reviews (see what is found under this heading)

Screenshot of step 5 showing example list of Reviews

  1. While looking at the above review documents you'll find some information has been redacted to maintain confidentiality of proprietary information. Even with redacted information, there is likely some useful information found in the drug's Review history.

Use the Review History for Patent Confirmation

When looking at your dosage form's patent, there may be multiple patents, and you may not be sure which patent is most relevant to your drug's dosage form. By looking at the review history you can get a good indicator if you've selected the correct patent that best demonstrates the dosage form.