/openfda/drug/approvals

POST /api/openfda/drug/approvals

Price: 1 credit

Get a Drugs@FDA approval record by its FDA application number

How to use it

Get a Drugs@FDA approval record by its FDA application number (NDA/ANDA/BLA). Returns the sponsor, the approved products (brand name, active ingredients, dosage form, route, marketing status, TE code) and the full submission history (type, status, status date, review priority and approval documents) plus the openfda block.

Parameters

• access-token string required

Request body

• timeout integer — Max scrapping execution timeout (in seconds) (default: 300; min: 20; max: 1500)
• id string required — Drugs@FDA application number (examples: "ANDA076708", "NDA021858"; minLength: 1)

Response

• @type string (default: "OpenfdaDrugApproval")
• application_number string required
• sponsor_name string nullable
• products array (default: [])
  • @type string (default: "OpenfdaApprovalProduct")
  • product_number string nullable
  • brand_name string nullable
  • dosage_form string nullable
  • route string nullable
  • marketing_status string nullable
  • te_code string nullable
  • reference_drug string nullable
  • reference_standard string nullable
  • active_ingredients array (default: [])
    • @type string (default: "OpenfdaNdcActiveIngredient")
    • name string required
    • strength string nullable
• submissions array (default: [])
  • @type string (default: "OpenfdaApprovalSubmission")
  • submission_type string nullable
  • submission_number string nullable
  • submission_status string nullable
  • submission_status_at integer nullable
  • review_priority string nullable
  • submission_class_code string nullable
  • submission_class_code_description string nullable
  • application_docs array (default: [])
    • @type string (default: "OpenfdaApprovalDoc")
    • id string nullable
    • doc_url string required
    • doc_type string nullable
    • date_at integer nullable
• openfda object nullable
  • @type string (default: "OpenfdaBlock")
  • application_number array (default: [])
  • brand_name array (default: [])
  • generic_name array (default: [])
  • manufacturer_name array (default: [])
  • product_ndc array (default: [])
  • package_ndc array (default: [])
  • product_type array (default: [])
  • route array (default: [])
  • substance_name array (default: [])
  • rxcui array (default: [])
  • unii array (default: [])
  • spl_id array (default: [])
  • spl_set_id array (default: [])
  • nui array (default: [])
  • pharm_class_cs array (default: [])
  • pharm_class_epc array (default: [])
  • pharm_class_moa array (default: [])
  • pharm_class_pe array (default: [])
  • is_original_packager array (default: [])
  • device_class string nullable
  • device_name string nullable
  • medical_specialty_description string nullable
  • regulation_number string nullable
  • fei_number array (default: [])
  • registration_number array (default: [])
  • k_number array (default: [])
  • pma_number array (default: [])
• web_url string (default: "")

Errors

• 422 — The request body did not validate Check the fields against this schema. A URN with the wrong prefix is the most common cause.
• 408 — The request ran past its time limit Raise `timeout` in the request body, up to the maximum this endpoint documents. Lowering `count` or turning off the `with_*` flags also helps, because less work finishes sooner.
• 412 — Application not found Retrying will not help: either the entity does not exist, or the input points at a different one.
• 429 — Too many requests: a rate limit or a usage window is exhausted When the response carries an X-Retry-After header, wait that many seconds and retry: the same number is in the body as `detail.retry_after`, and the limit clears once that window passes. The message in the body names the limit that was hit.
• 500 — Something broke on our side Retrying will not help. If it keeps happening, send us the X-Request-ID from the response headers.
• 529 — Rate limit reached, or the endpoint is overloaded Wait at least 30 seconds, then retry.

Response headers

• X-Error — Error message text (present only on error)
• X-Request-ID — Unique request identifier
• X-Execution-Time — Execution time in seconds
• X-Result-Count — How many records the body carries. 0 means an empty result, which is a normal answer and not by itself an error. A non-zero count can come back together with X-Error when the failure happened partway through — read this header and X-Error independently.
• X-Total-Available-Results — How many records exist for this query, when the endpoint can say. On a `dry_run` request this is the answer and the body is empty. It saturates: the endpoint's documented maximum means 'at least that many', any smaller number is exact.
• X-Warning — Present when the request body carried keys this endpoint does not document. They were ignored, so any filter you meant to apply through them did not apply. Check the spelling against this schema and retry.
• X-Retry-After — Seconds to wait before retrying. Present only on 429.