Regulatory Approvals Search

regulatory-approvalsNo success wrapper

Paginated search and listing of harmonised regulatory approval RECORDS (FDA Orange Book, FDA Purple Book, EMA). Supports full-text search plus exact, partial-match and linked-id filters, all AND-combined. Returns transformed records with resolved sponsors (direct entities; full sponsors_chain), drugs with ChEMBL ids, indications, regulatory flags, patents and exclusivity entries. Each record's 'approval_id' - public SOURCE:number form, e.g. FDA_ORANGE:020610 / EMA:EU/1/20/1528 - is the identifier the Regulatory Approvals Record, Label and History tools expect; the internal _key is no longer returned, so never use it. Use for applicant / trade name / ingredient lookups and orphan or marketing-status filters; use regulatory.profile for a curated single-drug profile and regulatory.landscape for aggregated multi-drug views.

When to use it

list approvals for an applicant, trade name or ingredient
filter approvals by source (FDA/EMA), marketing status or orphan designation
approvals linked to a sponsor, drug (ChEMBL) or disease (CURIE) id
inspect patents and exclusivity entries behind an applicant's approvals

Getting started

Base URL

https://app.caelrith.com/api/v1/tools

Authentication

Include your API key in the x-api-key header.

Parameters

Query parameters

Parameter	Type	Required	Description
search	string	No	Full-text search across trade name, applicant and ingredient (language-analyzed). Prefer the exact/partial filters below for precise matches.
source	string	No	Approval source registry to filter by. 'EMA' and 'EMA Union Register' are equivalent ('EMA' is normalized server-side). Allowed values: FDA_ORANGE, FDA_PURPLE, EMA, EMA Union Register
applicant	string	No	Case-insensitive partial match against the applicant company name. Does NOT expand to a corporate family - subsidiaries must be queried separately or via a resolved sponsor id.
trade_name	string	No	Case-insensitive partial match against the trade (brand) name. Get one via the Regulatory Approvals Record tool.
ingredient	string	No	Case-insensitive partial match against the active ingredient(s).
sponsor_id	string	No	Sponsor entity id; exact membership filter against the record's linked sponsor ids.
drug_id	string	No	ChEMBL-style drug id (e.g. CHEMBL1201599); exact membership filter against the record's linked drug ids.
disease_id	string	No	Disease ontology CURIE (e.g. MONDO:0004975); exact membership filter against the record's linked disease ids. Get CURIEs from the Disease Autocomplete tool.
status	string	No	Exact match against the record's marketing status (e.g. Rx, OTC, Disc).
is_orphan	boolean	No	Filter by orphan-drug designation. CAVEAT: the server coerces the query string to boolean, so 'false' is treated as true - this filter can only SELECT orphans, never exclude them (do not use it for 'non-orphan' searches).
page	number	No	Page number (default 1). Range: 1 to ∞
limit	number	No	Results per page (1-100, default 20). Range: 1 to 100
sort	string	No	Sort field: approval_date (default) or updated_at. Allowed values: approval_date, updated_at
order	string	No	Sort direction (default desc). Allowed values: asc, desc

Example request

curl -H "x-api-key: YOUR_API_KEY" \
  "https://app.caelrith.com/api/v1/regulatory"

Response envelope

This endpoint returns an implicit 2xx response - there is no success flag in the body.

{
  "data": { /* payload */ },
  "meta": { /* pagination, totals */ }
}

// No "success" flag on this endpoint - any 2xx JSON is a success.

Response shape

List responseAPPROVALS

Payload: data — Approvals

Exact total: meta.totalItems

Pagination: server-side via page and limit

Common row fields

Field	Description
approval_id	Approval ID
trade_name	Trade Name
applicant_raw	Applicant
source	Source
approval_date	Approval Date
marketing_status	Status

Empty results: No matching rows (HTTP 200)

Rows are product listings; approval_id is the PUBLIC identifier (FDA_ORANGE:020610 / FDA_PURPLE:BLA125514 / EMA:EU/1/20/1528) - feed it verbatim to the Regulatory Approvals Record, Label and History tools (the old internal _key is no longer returned). 'applicant_raw' is the raw applicant string; 'sponsors' rows are filtered to DIRECT entities (full hierarchy in 'sponsors_chain'), 'drugs' carry chembl_id values and 'indications' are resolved names. Linked-id filters match EXACTLY (sponsor_id = organizations/<key>, drug_id = ChEMBL id, disease_id = ontology CURIE e.g. EFO:0003767) - a wrong or differently formatted id returns an empty list, not an error. meta.totalItems is the exact total for the filters - quote it, never a page length.

Catalog version 0.0.0-generated · generated from the API source