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  • 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.

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Filters

Send these under filters.fda_purple_book in a 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.
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string
BM25 keyword match on the brand name (e.g. “Humira”, “Amjevita”). NULL for unbranded products — use proper_name.
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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.
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string
BM25 keyword match on the license holder (e.g. “Amgen”). Prefer the company root over the legal suffix.
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string
Exact BLA application number (e.g. “761024”). Cross-links to fda_biologic_rag_chunks. A BLA spans multiple presentation rows.
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string
Exact product number within a BLA (e.g. “001”). Only meaningful combined with bla_number.
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string
Exact US license number (e.g. “1726”).
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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.
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string
Exact marketing status: “Rx” (prescription), “Disc” / “Disc*” (discontinued), “OTC”. Match both “Disc” and “Disc*” for “discontinued”.Values: Rx, Disc, Disc*, OTC.
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string
Exact licensure status of the biologics license.Values: Licensed, Voluntarily Revoked, Revoked.
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string
Exact reviewing FDA center: “CDER” (drugs) or “CBER” (biologics/vaccines).Values: CDER, CBER.
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string
Exact submission type: “Original” or “Supplement”.Values: Original, Supplement.
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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.
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string
BM25 keyword match on the reference product’s brand name (e.g. “Humira”). NULL on 351(a) rows.
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string (date)
Inclusive lower bound on the FDA approval date (YYYY-MM-DD).
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string (date)
Inclusive upper bound on the FDA approval date (YYYY-MM-DD).
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string (date)
Inclusive lower bound on the reference-product exclusivity expiry (YYYY-MM-DD). Only 351(a) rows have this date.
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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.
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string (date)
Inclusive lower bound on the orphan-drug exclusivity expiry (YYYY-MM-DD).
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string (date)
Inclusive upper bound on the orphan-drug exclusivity expiry (YYYY-MM-DD).

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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