I'm working on a project that annotates FDA label text. We're trying to use the openFDA API to get information about specific NDA IDs. I'm trying to query information about NDA206038 using the /search endpoint. I get a 404 response.

However, when I look in Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206038 I get a valid page with all sorts of data.

Why is this particular NDA not available through openFDA? Is there a document somewhere that lists what types of labels are not indexed in openFDA?

The drug you are referring to -- ORKAMBI® (lumacaftor/ivacaftor) -- apparently has changed its dosage form. Approval of a new dosage form of a drug requires a new NDA. The most recent NDA approval for this drug is NDA211358, and openFDA will include only the most recent NDA number by design. The following query will return the results you would expect: https://api.fda.gov/drug/label.json?search=openfda.application_number:NDA211358.

  • Is there a way to query api.fda.gov and figure out that a particular NDA number is not the most recent? Right now if I query on a valid but non-recent NDA it gives me a NOT_FOUND response which looks exactly the same as a request for an invalid NDA ID like "blahblah" – Ryan Sep 11 at 17:27
  • Unfortunately, I don't think openFDA offers such capability. You can always get the most recent NDA off of the "openfda" section by querying by drug brand name, for example: api.fda.gov/drug/label.json?search=openfda.brand_name:ORKAMBI – Denis Krylov Sep 12 at 10:16

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