ASassyro
FDA registers

Search FDA registers

Search FDA's published registers, from Assyro's copies of FDA's own files, one per dataset: orphan-designations (Orphan Drug Designations and Approvals: generic and trade name, designation date, designated indication, designation status, sponsor, and each orphan approval with marketing approval date, labeled indication and exclusivity end date); inactive-ingredients (the Inactive Ingredient Database: per excipient, ROUTE and DOSAGE_FORM, the maximum POTENCY_AMOUNT per unit dose and MAXIMUM_DAILY_EXPOSURE FDA lists, with UNII and CAS number); postmarketing-requirements (open PMRs and 506B PMCs per NDA/BLA, and those closed in the last year: type such as 505(o)(3) or PREA, description, status, original final report due date); rems (every REMS, current or released: elements such as Medication Guide or ETASU, goals, products, versions); drug-master-files (the DMF list: number, type I-V, status active or inactive, holder, subject, submit date). Omit dataset to search all five. Find by product or ingredient name, holder (sponsor, applicant, DMF holder), application number, status, or words. Quote FDA's values with their column names; an IID maximum is what approved products contain, not a safety limit; a DMF on the list is not an FDA review. A dataset that is not loaded is reported as not searched: never read that as "none". Call read_fda_register_record for every approval, product or version of one entry.

get/v1/sources/fda-registers/search

Request

  • Base URL
    https://api.assyro.com
  • Auth
    none declared

Query parameters

dataset'orphan-designations' | 'inactive-ingredients' | 'postmarketing-requirements' | 'rems' | 'drug-master-files'

Search one register only. Omit for all five.

querystring

Words that must all appear in the entry (names, indication, description, subject, holder, identifiers), e.g. "Fabry disease" or "divalproex sodium".

productstring

Product, active ingredient, excipient or DMF subject name, substring match, e.g. "acalabrutinib", "magnesium stearate", "Ozempic".

holderstring

Orphan sponsor, PMR/PMC applicant or DMF holder, substring match, e.g. "Novo Nordisk".

applicationstring

NDA, BLA or ANDA number (postmarketing-requirements and rems), e.g. "209637" or "NDA 209637".

statusstring

FDA's status words, all of which must appear: orphan "designated", "approved", "withdrawn"; PMR/PMC "ongoing", "delayed", "fulfilled", "released"; REMS "current", "released"; DMF "active", "inactive".

routestring

Inactive ingredients: FDA's ROUTE, exact, e.g. "ORAL", "BUCCAL", "INTRAVENOUS".

dosageFormstring

Inactive ingredients: words of FDA's DOSAGE_FORM, all of which must appear, e.g. "tablet" (every tablet form) or "TABLET, FILM COATED".

dmfType'I' | 'II' | 'III' | 'IV' | 'V'

Drug master files: FDA's DMF type (II drug substance or product, III packaging, IV excipient, V reference information; I is no longer accepted).

dateFromstring

Earliest date of the entry's date (orphan designation date, PMR/PMC final report due date, REMS latest version date, DMF submit date): YYYY, YYYY-MM or YYYY-MM-DD.

dateTostring

Latest date of the entry's date, as dateFrom.

sort'relevance' | 'newest' | 'oldest'

relevance (default: exact name matches first, then newest), newest or oldest by the entry's date.

limitinteger

Records to return, default 8. total reports every match.

offsetinteger

Skip this many results (for paging), default 0.

Response

Matching records.

versionunknown required
totalinteger nullable required

Total matches the source reports, when it says.

notestring
summarystring[]

Changes

No recorded changes to this operation across all 1 revision of this API.