You can access the FDA Drug Approvals (Drugs@FDA) programmatically from your own applications by using the Apify API. You can also choose the language preference from below. To use the Apify API, you’ll need an Apify account and your API token, found in API & Integrations in Apify Console.

Python

JavaScript

CLI

OpenAPI

HTTP

MCP

{
  "openapi": "3.0.1",
  "info": {
    "version": "0.1",
    "x-build-id": "fim2o8BBDf88WaYYB"
  },
  "servers": [
    {
      "url": "https://api.apify.com/v2"
    }
  ],
  "paths": {
    "/acts/nexgenwatch~fda-drug-approvals/run-sync-get-dataset-items": {
      "post": {
        "operationId": "run-sync-get-dataset-items-nexgenwatch-fda-drug-approvals",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK"
          }
        }
      }
    },
    "/acts/nexgenwatch~fda-drug-approvals/runs": {
      "post": {
        "operationId": "runs-sync-nexgenwatch-fda-drug-approvals",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor and returns information about the initiated run in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK",
            "content": {
              "application/json": {
                "schema": {
                  "$ref": "#/components/schemas/runsResponseSchema"
                }
              }
            }
          }
        }
      }
    },
    "/acts/nexgenwatch~fda-drug-approvals/run-sync": {
      "post": {
        "operationId": "run-sync-nexgenwatch-fda-drug-approvals",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK"
          }
        }
      }
    }
  },
  "components": {
    "schemas": {
      "inputSchema": {
        "type": "object",
        "properties": {
          "sponsor": {
            "title": "Sponsor contains",
            "type": "array",
            "description": "Only deliver approvals whose sponsor (applicant company) matches one of these names, e.g. Pfizer.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "ingredient": {
            "title": "Active ingredient contains",
            "type": "array",
            "description": "Only deliver approvals whose active ingredient matches one of these, e.g. metformin.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "applicationType": {
            "title": "Application type",
            "type": "array",
            "description": "Restrict to these application types by prefix: NDA, ANDA, BLA.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "maxRecords": {
            "title": "Max approval records",
            "minimum": 1,
            "maximum": 20000,
            "type": "integer",
            "description": "Upper bound on approval records delivered this run (a buyer-requested cap). Leave empty for the built-in ceiling.",
            "default": 1000
          },
          "maxPages": {
            "title": "Max pages",
            "minimum": 1,
            "maximum": 400,
            "type": "integer",
            "description": "Safety ceiling on API pages read."
          },
          "pageLimit": {
            "title": "Records per page",
            "minimum": 1,
            "maximum": 1000,
            "type": "integer",
            "description": "Records requested per openFDA page (max 1000; default 100).",
            "default": 100
          },
          "minRequestIntervalSec": {
            "title": "Min request interval (seconds)",
            "minimum": 0,
            "type": "integer",
            "description": "Self-throttle between API pages to honour openFDA's rate limit (~240/min). Default under 1 second."
          },
          "userAgent": {
            "title": "User-Agent",
            "type": "string",
            "description": "Optional override for the identified contact User-Agent."
          }
        }
      },
      "runsResponseSchema": {
        "type": "object",
        "properties": {
          "data": {
            "type": "object",
            "properties": {
              "id": {
                "type": "string"
              },
              "actId": {
                "type": "string"
              },
              "userId": {
                "type": "string"
              },
              "startedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "finishedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "status": {
                "type": "string",
                "example": "READY"
              },
              "meta": {
                "type": "object",
                "properties": {
                  "origin": {
                    "type": "string",
                    "example": "API"
                  },
                  "userAgent": {
                    "type": "string"
                  }
                }
              },
              "stats": {
                "type": "object",
                "properties": {
                  "inputBodyLen": {
                    "type": "integer",
                    "example": 2000
                  },
                  "rebootCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "restartCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "resurrectCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "computeUnits": {
                    "type": "integer",
                    "example": 0
                  }
                }
              },
              "options": {
                "type": "object",
                "properties": {
                  "build": {
                    "type": "string",
                    "example": "latest"
                  },
                  "timeoutSecs": {
                    "type": "integer",
                    "example": 300
                  },
                  "memoryMbytes": {
                    "type": "integer",
                    "example": 1024
                  },
                  "diskMbytes": {
                    "type": "integer",
                    "example": 2048
                  }
                }
              },
              "buildId": {
                "type": "string"
              },
              "defaultKeyValueStoreId": {
                "type": "string"
              },
              "defaultDatasetId": {
                "type": "string"
              },
              "defaultRequestQueueId": {
                "type": "string"
              },
              "buildNumber": {
                "type": "string",
                "example": "1.0.0"
              },
              "containerUrl": {
                "type": "string"
              },
              "usage": {
                "type": "object",
                "properties": {
                  "ACTOR_COMPUTE_UNITS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_WRITES": {
                    "type": "integer",
                    "example": 1
                  },
                  "KEY_VALUE_STORE_LISTS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_INTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_EXTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_SERPS": {
                    "type": "integer",
                    "example": 0
                  }
                }
              },
              "usageTotalUsd": {
                "type": "number",
                "example": 0.00005
              },
              "usageUsd": {
                "type": "object",
                "properties": {
                  "ACTOR_COMPUTE_UNITS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_WRITES": {
                    "type": "number",
                    "example": 0.00005
                  },
                  "KEY_VALUE_STORE_LISTS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_INTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_EXTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_SERPS": {
                    "type": "integer",
                    "example": 0
                  }
                }
              }
            }
          }
        }
      }
    }
  }
}

FDA Drug Approvals (Drugs@FDA) OpenAPI definition

OpenAPI is a standard for designing and describing RESTful APIs, allowing developers to define API structure, endpoints, and data formats in a machine-readable way. It simplifies API development, integration, and documentation.

OpenAPI is effective when used with AI agents and GPTs by standardizing how these systems interact with various APIs, for reliable integrations and efficient communication.

By defining machine-readable API specifications, OpenAPI allows AI models like GPTs to understand and use varied data sources, improving accuracy. This accelerates development, reduces errors, and provides context-aware responses, making OpenAPI a core component for AI applications.

You can download the OpenAPI definitions for FDA Drug Approvals (Drugs@FDA) from the options below:

OpenAPI.json

If you’d like to learn more about how OpenAPI powers GPTs, read our blog post.

You can also check out our other API clients:

FDA Drug Approvals (Drugs@FDA) API in Python

FDA Drug Approvals (Drugs@FDA) API in JavaScript

FDA Drug Approvals (Drugs@FDA) API through CLI

FDA Drug Approvals (Drugs@FDA) API

FDA Drug Approval Tracker (openFDA)

data_drifter/fda-drug-approvals

Searches the openFDA API for drug approval data including NDAs, ANDAs, and BLAs. Returns drug names, sponsors, approval dates, dosage forms, routes, active ingredients, and submission details.

Curt Smith

FDA Drug Approvals Scraper API - Drugs@FDA Products

pink_comic/fda-drugs-at-fda-approvals-product-search

Search official openFDA Drugs@FDA application, product, and action records by brand, generic, sponsor, application, route, status, and date. Returns source-linked applications with nested products and submissions. FDA administrative evidence—not medical advice or proof of current availability.

Ava Torres

FDA Drug Approval & Recall Watch — Pharma Monitor

azureblue/fda-drug-approval-watch

Daily delta monitor of FDA drug approvals (Drugs@FDA) and drug recalls (openFDA enforcement) — for Pharma Regulatory, Pharmacovigilance, and US market access teams. Webhook-ready alerts.

azureblue

FDA Drug Approvals Tracker — NDA/BLA/ANDA API

nexgendata/fda-drug-approvals

Track FDA drug approvals via openFDA — NDA / BLA / ANDA / supplements with priority review, breakthrough, accelerated approval, orphan drug, fast track flags. Indication, dosage form, route, manufacturer. EvaluatePharma / Citeline / GlobalData alternative for pharma analysts.

NexGenData

Fda Drug Approval Timelines Api

jeeves_is_my_copilot/fda-drug-approval-timelines-api

Public data actor with normalized output.

Alexander Abernathy

FDA Drug Approval Monitor: Whole Market or Your Companies

datasignalslab/fda-drug-approval-monitor

Every Drugs@FDA action in the window, or just the manufacturers you follow. Approvals, supplements and priority reviews, scored as regulatory catalysts.

DataSignals Lab

FDA Drug Approvals Scraper - Drugs@FDA NDA ANDA BLA

scrapers_lat/fda-drug-approvals-scraper

Extract FDA drug approvals from Drugs@FDA: NDA, ANDA (generic) and BLA (biologic) applications, sponsor, brand and generic names, active ingredients, dosage form, route, marketing status, approval dates and the full submission history. Export JSON, CSV or Excel.

Scrapers Lat

FDA Drug Approvals Scraper

parseforge/fda-drug-approvals-scraper

Scrapes FDA drug approval records from the openFDA Drugs@FDA endpoint. Each row returns the application number, sponsor, active ingredients, and approval date.

ParseForge

US Market Events Scraper (FDA, SEC, Contracts, Insiders)

claudethegoat/us-material-events-monitor

Unified daily feed of FDA drug approvals (NDA/BLA only, no generics), SEC 8-K material-event filings, $1M+ federal contract awards from USAspending.gov, and Form 4 insider buy/sell transactions from OpenInsider. One normalized JSON schema across all four high-signal US public-data sources.