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美国FDA批准药品

本数据库收载了1939年至今美国FDA批准在美国上市、暂定批准的近5万条药品信息，主要包括：商品名、申请机构、申请号、活性成分、剂型给药途径、是否参比制剂、是否生物等效试验对照药品、治疗等效代码、药品提交类型（新药化学类别）和审评类别、审批历史信息等。可查询药品审批注册信息、药品说明书及相关批准文件等。
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概述

本数据库收载了1939年至今美国FDA批准在美国上市、暂定批准的近5万条药品信息，主要包括：商品名、申请机构、申请号、活性成分、剂型给药途径、是否参比制剂、是否生物等效试验对照药品、治疗等效代码、药品提交类型（新药化学类别）和审评类别、审批历史信息等。可查询药品审批注册信息、药品说明书及相关批准文件等。

数据结构及样例

{
  "药品名称":"ZOMIG",
  "申请号":"021450",
  "申请类型":"NDA（新药申请）",
  "申请途径":"505(b)",
  "规格":"2.5MG/SPRAY", 
  "剂型/给药途径":"SPRAY;NASAL",
  "申报企业":"AMNEAL",
  "活性成分":["ZOLMITRIPTAN"],
  "活性成分（中）":"佐米曲普坦",
  "提交类型":"Type 3新剂型",
  "市场状态":["处方药"],
  "参比制剂(RLD)":"是",
  "对照制剂(RS)":"是",
  "治疗等效代码":"AB",
  "说明书":["Label (PDF) （2018-12-21·发布、链接：内部链接）"],
  "审评文件":["(PDF) Pharmacology Review(s)（2003-09-30·发布、链接：内部链接1）",
"(PDF) Statistical Review(s)（2003-09-30·发布、链接：内部链接2）"],
  "官网":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&ApplNo=021450",
  "孤儿药":"",
  "橙皮书/紫皮书":"橙皮书",
  "首仿药":"", 
  "无仿药的已过专利期及独占期药品":"",
  "ATC分类":"神经系统药物>镇痛药>抗偏头痛药>选择性5-羟色胺（5HT1）促效药",
  "药理分类":[""],
  "辅料":"LANOLIN;PETROLATUM;WATER（示例数据）",
  "黑框警告":"WARNING — INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.（示例数据）",
  "审评通道":["加速审评","竞争性仿制药疗法"],//示例数据
  "加速审评":[{"FDA接收时间":"2008-11-03","加速审评批准时间":"2008-11-03","审评耗时（月）"："6","适应症":"FORTHETREATMENTOFGLIOBLASTOMAWITHPROGRESSIVEDISEASEFOLLOWINGPRIORTHERAPY","适应症加速审评的撤销状态":"Converted","撤销日期":"2017-05-12","批准依据"："Based on a Surrogate Endpoint"}],//示例数据
  "突破疗法":[{"提交序号":"SUPPLEMENT-85","批准时间":"2022-09-05","适应症":"Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency"}] ,//示例数据
  "快速通道":[{"批准时间":"2022-09-05","适应症":"Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency"}]，//示例数据
  "竞争性仿制疗法（CGT）":[{"RLD名称":"ZOMIG","RLD申请号":"ZOMIG","ANDA批准日期":"2025-04-15","是否资格获得CGT市场排他权":"No","CGT市场排他权收回":"N/A","以CGT市场排他权上市日期":"N/A","官网":"https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals"}]，//示例数据
  "Para IV声明详情":[{"规格":"5 mg/spray","ANDA申请数量":"1","ANDA申请日期":"2013-11-14","180天独占期决定状态":"Extinguished","180天独占期决定发布日期":"2021-01-12","首个申请批准时间"：""}, {"规格":"2.5 mg/spray","ANDA申请数量":"1","ANDA申请日期":"2016-06-09","180天独占期决定状态":"Extinguished","180天独占期决定发布日期":"2020-07-27"}],
}