Is there an identifier that might indicate 505(b)(1) vs 505(b)(2) filing?

Question

I'm skimming through the Drugs@FDA dataset, and I'm wondering if any of the identifiers would tell me which pathway the application went through. Of the options, SubmissionClassCodeID seems most likely, but I'm not sure how to read the definitions. Any ideas?

Answer 1

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 exactly how accurate that method would be.