FDA drug approvals (Drugs@FDA)

GET https://api.api.sh/openfda/v1/drug-approvals
1 credit / call government & registries try it in the playground →

Drug applications approved by the FDA (Drugs@FDA): application number, sponsor, products (brand name, active ingredients and strengths, dosage form, route, marketing status, therapeutic-equivalence code, reference drug) and the submission history (type, number, status and date, review priority, class, documents such as labels and letters). Filters accept a comma list (any of the values). Pass next_page back as page; null on the last page.

With count_by=<field> the response gives facet counts of the matching records by that field instead of the records: items of {term, count} (top count_limit). Text fields count whole values on their .exact index (e.g. count_by=openfda.manufacturer_name.exact); date fields give a time series grouped by count_interval (items of {period, count}). The other filters narrow what is counted.

Every response includes credits_used: the credits this call cost.

Parameters

nametypedescription
brand string Brand name. Example: lipitor
application_number string Application number (e.g. NDA020702).
sponsor string Sponsor (company) name.
ingredient string Active ingredient.
generic string Generic name.
dosage_form string Dosage form (e.g. TABLET).
route string Route (e.g. ORAL).
marketing_status prescription | otc | discontinued | none Product marketing status.
submission_type orig | suppl Original or supplement submissions.
review_priority priority | standard Review priority.
q string Free-text words; every word must appear somewhere in the record.
from string Earliest date (YYYY-MM-DD) of the route's main date field.
to string Latest date (YYYY-MM-DD).
search string An openFDA query expression added to the filters with AND, for fields the named filters do not cover (e.g. openfda.route:"TOPICAL").
sort application_number | status_date Sort field (default: relevance, or the newest first where noted).
order desc | asc Sort order (default desc).
limit integer Results per page.
page integer Page number (1-based). Pass next_page back as page; null on the last page.
count_by string Count the matching records by this field (an openFDA field name, e.g. classification.exact, openfda.brand_name.exact, or a date field).
count_limit integer Number of top terms for count_by (1-1000; default 100).
count_interval year | month | day Grouping of a date count_by: year (default), month or day.

Every endpoint also takes fresh, raw, fields (see lean responses and caching).

Example

curl "https://api.api.sh/openfda/v1/drug-approvals?brand=lipitor" \
  -H "x-api-key: $APISH_KEY"

Response

A JSON object with the fields described above, plus raw (the source's own data), cached, fetched_at and credits_used. Errors return {"success": false, "error": "…"} with the HTTP status (see errors). A lookup that ran but found nothing (404) costs the price above; refused calls and errors on our side are free (what's charged).

The fastest way to see the full response is the playground: it runs this endpoint with your account and shows the exact JSON.