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  • Dataset id: fda_crl
  • Jurisdiction: US · FDA
  • Date field: crl_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_crl 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 date_from and date_to below, so give a date in one place only.
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string
Keyword match on drug name (BM25 tokenized). Example: ‘lecanemab’.
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string
Keyword match on company (BM25 tokenized). Example: ‘Eisai’.
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string
Exact application number. Example: ‘NDA 214787’.
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string
Exact application type. Values: NDA, BLA, ANDA.Values: NDA, BLA, ANDA.
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string
Keyword match on therapeutic area (BM25 tokenized). Example: ‘oncology’.
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string
Exact approval status filter. Values: ‘Approved’ or ‘Unapproved’.Values: Approved, Unapproved.
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string (date)
Inclusive lower bound on CRL date (YYYY-MM-DD).
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string (date)
Inclusive upper bound on CRL date (YYYY-MM-DD).

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Fields

Each result from this dataset has these in fields: application_number, approval_status, approver_center, approver_name, approver_title, company_address, company_name, company_rep, crl_date, drug_name, fda_application_type, fda_url, filename, therapeutic_area, title