> ## Documentation Index
> Fetch the complete documentation index at: https://docs.rhizomeai.com/llms.txt
> Use this file to discover all available pages before exploring further.

# FDA Purple Book

> Search filters and result fields of fda_purple_book.

* **Dataset id:** `fda_purple_book`
* **Jurisdiction:** US · FDA
* **Date field:** `approval_date`. The search's top-level `date_from` and `date_to` filter on it.
* **Access:** any API key.

## Filters

Send these under `filters.fda_purple_book` in a [search](/api-reference/v3/search) request. A filter not listed here, or a value of the wrong type, is a 400. The top-level `date_from` and `date_to` set `approval_date_from` and `approval_date_to` below, so give a date in one place only.

<ParamField body="proprietary_name" type="string">
  BM25 keyword match on the brand name (e.g. "Humira", "Amjevita"). NULL for unbranded products — use proper\_name.
</ParamField>

<ParamField body="proper_name" type="string">
  BM25 keyword match on the nonproprietary / proper name (e.g. "adalimumab", "infliximab-dyyb"). Always present; biosimilars carry a 4-letter suffix on the proper name.
</ParamField>

<ParamField body="applicant" type="string">
  BM25 keyword match on the license holder (e.g. "Amgen"). Prefer the company root over the legal suffix.
</ParamField>

<ParamField body="bla_number" type="string">
  Exact BLA application number (e.g. "761024"). Cross-links to fda\_biologic\_rag\_chunks. A BLA spans multiple presentation rows.
</ParamField>

<ParamField body="product_no" type="string">
  Exact product number within a BLA (e.g. "001"). Only meaningful combined with bla\_number.
</ParamField>

<ParamField body="license_number" type="string">
  Exact US license number (e.g. "1726").
</ParamField>

<ParamField body="license_type" type="string">
  Exact license type: "351(a)" = reference (originator) biologic; "351(k) Biosimilar" = biosimilar; "351(k) Interchangeable" = interchangeable biosimilar.

  Values: `351(a)`, `351(k) Biosimilar`, `351(k) Interchangeable`.
</ParamField>

<ParamField body="marketing_status" type="string">
  Exact marketing status: "Rx" (prescription), "Disc" / "Disc\*" (discontinued), "OTC". Match both "Disc" and "Disc\*" for "discontinued".

  Values: `Rx`, `Disc`, `Disc*`, `OTC`.
</ParamField>

<ParamField body="licensure" type="string">
  Exact licensure status of the biologics license.

  Values: `Licensed`, `Voluntarily Revoked`, `Revoked`.
</ParamField>

<ParamField body="center" type="string">
  Exact reviewing FDA center: "CDER" (drugs) or "CBER" (biologics/vaccines).

  Values: `CDER`, `CBER`.
</ParamField>

<ParamField body="submission_type" type="string">
  Exact submission type: "Original" or "Supplement".

  Values: `Original`, `Supplement`.
</ParamField>

<ParamField body="ref_product_proper_name" type="string">
  BM25 keyword match on the reference product's proper name (e.g. "adalimumab"). Finds all biosimilars of an originator. NULL on 351(a) rows.
</ParamField>

<ParamField body="ref_product_proprietary_name" type="string">
  BM25 keyword match on the reference product's brand name (e.g. "Humira"). NULL on 351(a) rows.
</ParamField>

<ParamField body="approval_date_from" type="string (date)">
  Inclusive lower bound on the FDA approval date (YYYY-MM-DD).
</ParamField>

<ParamField body="approval_date_to" type="string (date)">
  Inclusive upper bound on the FDA approval date (YYYY-MM-DD).
</ParamField>

<ParamField body="ref_product_exclusivity_exp_from" type="string (date)">
  Inclusive lower bound on the reference-product exclusivity expiry (YYYY-MM-DD). Only 351(a) rows have this date.
</ParamField>

<ParamField body="ref_product_exclusivity_exp_to" type="string (date)">
  Inclusive upper bound on the reference-product exclusivity expiry (YYYY-MM-DD). Use with \_from to find originators whose exclusivity expires in a window.
</ParamField>

<ParamField body="orphan_exclusivity_exp_from" type="string (date)">
  Inclusive lower bound on the orphan-drug exclusivity expiry (YYYY-MM-DD).
</ParamField>

<ParamField body="orphan_exclusivity_exp_to" type="string (date)">
  Inclusive upper bound on the orphan-drug exclusivity expiry (YYYY-MM-DD).
</ParamField>

## Fields

Each result from this dataset has these in `fields`:

`applicant`, `approval_date`, `bla_number`, `center`, `date_of_first_licensure`, `dosage_form`, `first_interchangeable_exclusivity_exp_date`, `id`, `interchangeable_approval_date`, `license_number`, `license_type`, `licensure`, `marketing_status`, `orphan_exclusivity_exp_date`, `patent_list_provided`, `product_no`, `product_presentation`, `proper_name`, `proprietary_name`, `ref_product_exclusivity_exp_date`, `ref_product_proper_name`, `ref_product_proprietary_name`, `route`, `strength`, `submission_type`, `supplement_number`, `url`


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