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I am trying to list all of the approved drugs in a particular year, (e.g. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021), but when I try going through the searchable fields I am not able to find anything relevant. How might I do this?

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The Drugs@FDA endpoint is likely the best to fit your needs. You would want to search for records with submission status of "AP" (approved). Also, you would want to look for submission types indicating a new drug application (for example, Type 2 - New Active Ingredient). Finally, if you know the year, you can filter by the submission status date falling into that year.

Here is an example for the year of 1981:

openFDA API Call

Hopefully this helps

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  • Thanks for the answer, if I try with submission_status: AP and submission_status_date. it would return supplemental submission approval records as well. but I need only original approvals made in that year. how I can filter supplement submissions? Nov 9, 2021 at 7:17

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