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openFDA builds its Drugs@FDA dataset from the downloadable data files at the FDA. Unfortunately, the information you are looking for is currently absent from these files: if you scroll down to the ER diagram on that page you will see a note saying ActionTypes_Lookup (a linking table will be provided in the near future) The "linking table" hasn't ...


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This varies across the openFDA datasets; most datasets have a field or a combination of fields that could be used to uniquely identify a record. Device Events uses mdr_report_key as the key. Drug Events uses safetyreportid. And so on. I agree the documentation could be more clear on what field(s) is the key for each dataset.


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Unfortunately, the Drugs@FDA dataset does not have a field that could be used to readily distinguish 505(b)(1) and 505(b)(2) applications. You could try parsing the content of the Approval Letter that is attached to the submission via the application_docs array -- the API does expose that -- to look for 505(b)(1) vs 505(b)(2) indication, but we are unsure on ...


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