{
  "id": "klonopin",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-04",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "KLONOPIN",
    "generic": "氯硝西泮",
    "aliases": [
      "KLONOPIN",
      "Klonopin",
      "clonazepam",
      "clonazepam tablets",
      "氯硝西泮",
      "氯硝西泮片",
      "氯硝安定",
      "NDA 017533",
      "61269-605-10",
      "61269-610-10",
      "61269-620-10",
      "KLONOPIN 0.5",
      "KLONOPIN 1",
      "KLONOPIN 2"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "精神健康",
    "sourceArchiveMarket": "美国当前公开标签：KLONOPIN 0.5 mg、1 mg、2 mg 三种 100 片瓶装；公开标签不等于目标市场批准、实时供应或购买资格",
    "dosageFormClass": "KLONOPIN 氯硝西泮 C-IV 口服片：0.5 mg、1 mg、2 mg；各为 100 片瓶装",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1975-06-04（FDA Drugs@FDA 所列美国初始批准日期）",
    "archiveSponsorText": "H2-Pharma / CHEPLAPHARM / FDA 与 DailyMed 当前公开监管记录"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "clonazepam orally disintegrating tablets",
      "KLONOPIN Wafers",
      "clonazepam injection",
      "氯硝西泮口崩片",
      "VALIUM",
      "XANAX"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-klonopin-clonazepam-tablet-0-5mg-100-bottle-ndc-6126960510",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2025-12-01 更新；SPL v6）",
        "en": "Current U.S. DailyMed label (updated 1 Dec 2025; SPL v6)"
      },
      "dosageForm": {
        "zh": "KLONOPIN 氯硝西泮口服片（C-IV）",
        "en": "KLONOPIN clonazepam oral tablet (C-IV)"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 61269-605-10",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯硝西泮 0.5 mg；100 片瓶装",
        "en": "Clonazepam 0.5 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-005.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯硝西泮",
            "en": "clonazepam"
          },
          "value": 0.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-04",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "橙色",
          "en": "orange"
        },
        "shape": {
          "zh": "圆形、K 形穿孔、可见二等分刻痕",
          "en": "round with K-shaped perforation and a two-piece score"
        },
        "imprint": "1/2;KLONOPIN",
        "scoreStatus": "scored_exact_label_not_universal_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_088098fd80958691",
        "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（SPL v6）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-klonopin-clonazepam-tablet-1mg-100-bottle-ndc-6126961010",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2025-12-01 更新；SPL v6）",
        "en": "Current U.S. DailyMed label (updated 1 Dec 2025; SPL v6)"
      },
      "dosageForm": {
        "zh": "KLONOPIN 氯硝西泮口服片（C-IV）",
        "en": "KLONOPIN clonazepam oral tablet (C-IV)"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 61269-610-10",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯硝西泮 1 mg；100 片瓶装",
        "en": "Clonazepam 1 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-006.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯硝西泮",
            "en": "clonazepam"
          },
          "value": 1,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-04",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "蓝色",
          "en": "blue"
        },
        "shape": {
          "zh": "圆形、K 形穿孔、无刻痕",
          "en": "round with K-shaped perforation and no score"
        },
        "imprint": "1;KLONOPIN",
        "scoreStatus": "not_scored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_088098fd80958691",
        "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（SPL v6）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-klonopin-clonazepam-tablet-2mg-100-bottle-ndc-6126962010",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2025-12-01 更新；SPL v6）",
        "en": "Current U.S. DailyMed label (updated 1 Dec 2025; SPL v6)"
      },
      "dosageForm": {
        "zh": "KLONOPIN 氯硝西泮口服片（C-IV）",
        "en": "KLONOPIN clonazepam oral tablet (C-IV)"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 61269-620-10",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯硝西泮 2 mg；100 片瓶装",
        "en": "Clonazepam 2 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-007.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯硝西泮",
            "en": "clonazepam"
          },
          "value": 2,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-04",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "圆形、K 形穿孔、无刻痕",
          "en": "round with K-shaped perforation and no score"
        },
        "imprint": "2;KLONOPIN",
        "scoreStatus": "not_scored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_088098fd80958691",
        "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（SPL v6）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-klonopin-clonazepam-tablet-0-5mg-100-bottle-ndc-6126960510",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-005.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img",
    "alt": "KLONOPIN 氯硝西泮 0.5 mg、NDC 61269-605-10、100 片瓶装在 DailyMed 当前标签中的展示图",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前公开标签（2025-12-01 更新；SPL v6）",
    "presentation": "KLONOPIN 氯硝西泮 0.5 mg、NDC 61269-605-10、100 片瓶装展示面",
    "notice": "图片只帮助核对这一准确美国标签产品的商品名、通用名、每片强度、NDC、瓶装数量与外观线索；不用于鉴定真伪，也不代表其他规格、口崩片、其他氯硝西泮产品、其他市场、当前库存或任何个人用药方案。",
    "source": {
      "id": "src_088098fd80958691",
      "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签与包装图（SPL v6）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "KLONOPIN 说明书放大阅读：先防止镇静叠加与突然停用",
      "en": "KLONOPIN label reading: prevent additive sedation and abrupt withdrawal first"
    },
    "summary": {
      "zh": "当前标签以黑框警告提醒阿片类合用、滥用/误用/成瘾及身体依赖和停药反应。老人、多药使用者或有呼吸问题的人，应优先核对嗜睡、认知和动作受损、跌倒、呼吸抑制以及全部镇静药；不要自行骤停或照搬网上减量表。",
      "en": "The current label uses a boxed warning for opioid co-use, abuse/misuse/addiction, physical dependence and withdrawal reactions. Older adults, people using several medicines or those with respiratory problems should prioritise review of somnolence, cognitive and motor impairment, falls, respiratory depression and every sedating medicine; do not abruptly self-stop or copy an online taper."
    },
    "checks": [
      {
        "zh": "0.5、1、2 mg 分别是每片标签含量，100 tablets 是每瓶片数。数字不能相加，也不能从剩余片数或症状自行计算今天吃几片。",
        "en": "The 0.5, 1 and 2 mg figures are labelled amounts per tablet, while 100 tablets is the bottle count. Do not add these numbers or calculate today's tablet count from remaining tablets or symptoms."
      },
      {
        "zh": "当前标签要求片剂用水整片吞服。0.5 mg 的刻痕是准确产品线索，不等于任何人都可自行掰半；1 mg 和 2 mg 当前产品为无刻痕片。",
        "en": "The current label directs swallowing the tablet whole with water. The 0.5 mg score is an exact-product clue, not universal permission to halve it; the current 1 mg and 2 mg products are unscored."
      },
      {
        "zh": "阿片类、酒精、其他苯二氮䓬类、助眠药、镇静性抗过敏药及其他中枢抑制药可能叠加。标签警示阿片类联用可导致深度镇静、呼吸抑制、昏迷和死亡；明显嗜睡、呼吸变慢、意识异常或叫不醒应立即使用当地急救。",
        "en": "Opioids, alcohol, other benzodiazepines, sleep medicines, sedating antihistamines and other CNS depressants may add effects. The label warns that opioid co-use can cause profound sedation, respiratory depression, coma and death; marked somnolence, slowed breathing, altered awareness or inability to wake requires local emergency services."
      },
      {
        "zh": "持续使用可形成身体依赖；突然停用或快速减量可出现危及生命的急性停药反应，包括癫痫发作。减量必须是针对个人的专业方案，不能按 VALIUM、XANAX 或另一种苯二氮䓬药的 mg 一比一换算。",
        "en": "Continued use can produce physical dependence. Abrupt stopping or rapid reduction can cause life-threatening acute withdrawal reactions, including seizures. Tapering must be individualised by a professional and cannot use one-for-one milligram conversion from VALIUM, XANAX or another benzodiazepine."
      },
      {
        "zh": "老人更容易出现镇静、混乱、动作和协调受损、跌倒等问题；肝病、肾功能问题、慢阻肺或睡眠呼吸暂停，以及其他抗癫痫药也应在完整药单中优先核对。",
        "en": "Older adults are more vulnerable to sedation, confusion, impaired movement and coordination, and falls. Liver disease, renal impairment, COPD or sleep apnoea, and other antiseizure medicines also require priority review in the complete medicine list."
      }
    ],
    "source": {
      "id": "src_088098fd80958691",
      "label": "DailyMed（NLM）：KLONOPIN 当前美国公开标签——黑框警告、老年人使用、呼吸风险与相互作用",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "KLONOPIN 机制阅读：增强 GABA 活性不等于可以自行换药",
      "en": "KLONOPIN mechanism reading: enhancing GABA activity does not permit self-switching"
    },
    "summary": {
      "zh": "当前标签说明其抗癫痫和抗惊恐的确切机制尚不清楚，但认为可能与增强中枢神经系统主要抑制性神经递质 GABA 的活性有关。机制解释不能变成个人选药、剂量、基因检测或联用规则。",
      "en": "The current label says the precise antiseizure and antipanic mechanisms are unknown, but may relate to enhancing activity of GABA, the major inhibitory neurotransmitter in the CNS. A mechanism description cannot become an individual medicine choice, dose, genetic test or co-use rule."
    },
    "checks": [
      {
        "zh": "“增强 GABA 活性”是药理线索，不能预测某个人会不会嗜睡、跌倒、产生依赖或出现停药反应。",
        "en": "‘Enhances GABA activity’ is a pharmacology clue and cannot predict an individual's somnolence, falls, dependence or withdrawal reactions."
      },
      {
        "zh": "KLONOPIN、VALIUM、XANAX 即使同属苯二氮䓬类，也不是可以按商品名、颜色或 mg 一比一换算、叠加或轮换的同一产品。",
        "en": "KLONOPIN, VALIUM and XANAX may share the benzodiazepine class, but they are not one product that can be converted, combined or rotated one-for-one by brand, colour or milligrams."
      },
      {
        "zh": "网页不依据机制建议常规全基因筛查。个人适用性仍要结合诊断、呼吸和肝肾情况、完整药单、既往反应与目标市场现行说明书。",
        "en": "The site does not recommend routine whole-genome screening from this mechanism. Individual suitability still requires diagnosis, respiratory and liver/kidney status, the complete medicine list, prior response and the current target-market label."
      }
    ],
    "source": {
      "id": "src_088098fd80958691",
      "label": "DailyMed（NLM）：KLONOPIN 当前美国公开标签——临床药理作用机制",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "KLONOPIN",
      "generic": "氯硝西泮",
      "dosageFormClass": "KLONOPIN 氯硝西泮 C-IV 口服片：0.5 mg、1 mg、2 mg；各为 100 片瓶装"
    },
    "labelSource": {
      "id": "src_088098fd80958691",
      "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（2025-12-01 更新；SPL v6）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_088098fd80958691",
          "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（2025-12-01 更新；SPL v6）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "美国国家医学图书馆 DailyMed",
          "en": "U.S. National Library of Medicine DailyMed"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "公开药品标签",
          "en": "Public medicine label"
        },
        "reviewedAt": "2026-09-04",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_c226b8c9c6756f9d",
          "label": "FDA Drugs@FDA：KLONOPIN NDA 017533 产品与 RLD/RS 记录",
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017533",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-09-04",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_d4929922ecd19b2e",
          "label": "FDA：KLONOPIN 2023 美国处方信息（NDA 017533/S-062）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-09-04",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      }
    ],
    "recordRoute": {
      "status": "product_level_public_record_verified",
      "authority": {
        "zh": "美国国家医学图书馆 DailyMed",
        "en": "U.S. National Library of Medicine DailyMed"
      },
      "market": {
        "zh": "美国",
        "en": "United States"
      },
      "recordType": {
        "zh": "公开药品标签",
        "en": "Public medicine label"
      },
      "reviewedAt": "2026-09-04",
      "scope": {
        "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
        "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
      }
    },
    "channels": [
      {
        "id": "china-nmpa-drug-evaluation-centre",
        "authority": "NMPA 药品评价中心",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "title": {
          "zh": "药物警戒快讯与安全警示",
          "en": "Drug-vigilance bulletins and safety notices"
        },
        "purpose": {
          "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。",
          "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item."
        },
        "source": {
          "id": "src_05ff2860226564d4",
          "label": "国家药监局药品评价中心：药物警戒与安全警示入口",
          "url": "https://www.cdr-adr.org.cn/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-drug-safety-communications",
        "authority": "FDA",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "药物安全通讯",
          "en": "Drug Safety Communications"
        },
        "purpose": {
          "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。",
          "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications."
        },
        "source": {
          "id": "src_9177df9e1825aa72",
          "label": "FDA：Drug Safety Communications",
          "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-medwatch",
        "authority": "FDA MedWatch",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "安全信息与严重问题报告",
          "en": "Safety information and serious-problem reporting"
        },
        "purpose": {
          "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。",
          "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality."
        },
        "source": {
          "id": "src_e4739cd55d27ab51",
          "label": "FDA：MedWatch 药品安全信息与不良事件报告计划",
          "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "ema-pharmacovigilance",
        "authority": "EMA",
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "title": {
          "zh": "药物警戒概览与 EudraVigilance",
          "en": "Pharmacovigilance overview and EudraVigilance"
        },
        "purpose": {
          "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。",
          "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment."
        },
        "source": {
          "id": "src_2ad42a3deae747d1",
          "label": "EMA：Pharmacovigilance overview",
          "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "javascript_or_cookie_controls",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mhra-drug-safety-update",
        "authority": "MHRA",
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "title": {
          "zh": "Drug Safety Update",
          "en": "Drug Safety Update"
        },
        "purpose": {
          "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。",
          "en": "Primary UK MHRA medicine-safety updates for professionals and the public."
        },
        "source": {
          "id": "src_23fdbe67abeafc63",
          "label": "MHRA：Drug Safety Update",
          "url": "https://www.gov.uk/drug-safety-update",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "pmda-drug-safety",
        "authority": "PMDA",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "title": {
          "zh": "药品安全信息",
          "en": "Medicine safety information"
        },
        "purpose": {
          "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。",
          "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents."
        },
        "source": {
          "id": "src_06d6be2880f12024",
          "label": "PMDA：Safety Information Regarding Drugs",
          "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mfds-drug-safety-letters",
        "authority": "MFDS",
        "market": {
          "zh": "韩国",
          "en": "Republic of Korea"
        },
        "title": {
          "zh": "药品安全性书信",
          "en": "Medicine safety letters"
        },
        "purpose": {
          "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。",
          "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case."
        },
        "source": {
          "id": "src_2d7f5018cd05eff4",
          "label": "MFDS：药品安全性书信（韩文原始资料）",
          "url": "https://www.mfds.go.kr/brd/m_545/list.do",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "KR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "hsa-adverse-events",
        "authority": "HSA",
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "title": {
          "zh": "不良反应报告与药物安全信息",
          "en": "Adverse-event reporting and medicine-safety information"
        },
        "purpose": {
          "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。",
          "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information."
        },
        "source": {
          "id": "src_9240397d5a8574c1",
          "label": "HSA：Report adverse events",
          "url": "https://www.hsa.gov.sg/adverse-events/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "health-canada-medeffect-advisories",
        "authority": "Health Canada",
        "market": {
          "zh": "加拿大",
          "en": "Canada"
        },
        "title": {
          "zh": "MedEffect 加拿大：建议、警告与召回",
          "en": "MedEffect Canada: advisories, warnings and recalls"
        },
        "purpose": {
          "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。",
          "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item."
        },
        "source": {
          "id": "src_212ec921fa6634ad",
          "label": "Health Canada：MedEffect Canada 建议、警告与召回",
          "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "tga-safety-alerts",
        "authority": "TGA",
        "market": {
          "zh": "澳大利亚",
          "en": "Australia"
        },
        "title": {
          "zh": "药品安全警示",
          "en": "Medicine safety alerts"
        },
        "purpose": {
          "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。",
          "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products."
        },
        "source": {
          "id": "src_ffe6142814f88fac",
          "label": "TGA：Safety alerts",
          "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "AU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "swissmedic-pharmacovigilance",
        "authority": "Swissmedic",
        "market": {
          "zh": "瑞士",
          "en": "Switzerland"
        },
        "title": {
          "zh": "药物警戒与不良反应报告",
          "en": "Pharmacovigilance and suspected adverse-reaction reporting"
        },
        "purpose": {
          "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。",
          "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality."
        },
        "source": {
          "id": "src_c854f813ce2671df",
          "label": "Swissmedic：Pharmacovigilance",
          "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "CH",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "medsafe-safety-communications",
        "authority": "Medsafe",
        "market": {
          "zh": "新西兰",
          "en": "New Zealand"
        },
        "title": {
          "zh": "药品安全通讯",
          "en": "Medicine safety communications"
        },
        "purpose": {
          "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。",
          "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information."
        },
        "source": {
          "id": "src_3510c1a523ec9769",
          "label": "Medsafe：Safety Communications",
          "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "NZ",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "sahpra-safety-information",
        "authority": "SAHPRA",
        "market": {
          "zh": "南非",
          "en": "South Africa"
        },
        "title": {
          "zh": "药物安全信息、警示与药物警戒",
          "en": "Medicine safety information, alerts and pharmacovigilance"
        },
        "purpose": {
          "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。",
          "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information."
        },
        "source": {
          "id": "src_25b0aaefee742163",
          "label": "SAHPRA：Safety Information Updates / Pharmacovigilance",
          "url": "https://www.sahpra.org.za/safety-information-and-updates/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "ZA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "who-medicine-safety-alerts",
        "authority": "WHO",
        "market": {
          "zh": "全球",
          "en": "Global"
        },
        "title": {
          "zh": "药品与疫苗安全警示档案",
          "en": "Medicine and vaccine safety-alert archive"
        },
        "purpose": {
          "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。",
          "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market."
        },
        "source": {
          "id": "src_9a7dc56ec34c7e1a",
          "label": "WHO：Safety alerts for medicines and vaccines",
          "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "GLOBAL",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "anvisa-pharmacovigilance",
        "authority": "Anvisa",
        "market": {
          "zh": "巴西",
          "en": "Brazil"
        },
        "title": {
          "zh": "药物警戒、警示与 VigiMed",
          "en": "Pharmacovigilance, alerts and VigiMed"
        },
        "purpose": {
          "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。",
          "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item."
        },
        "source": {
          "id": "src_5de362c12580111d",
          "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）",
          "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "BR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      }
    ],
    "notices": [],
    "boundary": {
      "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。",
      "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline."
    },
    "scope": "official_routes_only_no_live_alert_inference"
  },
  "archive": {
    "summary": "KLONOPIN 是氯硝西泮口服片的美国品牌监管档案。本页把 0.5 mg、1 mg、2 mg 三个当前公开标签产品分别绑定到准确 NDC、100 片瓶装、颜色、刻印、刻痕状态和一手来源；包装数字、颜色、K 形穿孔或共同的苯二氮䓬类别都不能转化为个人片数、掰片、减量、停用、联用或替换方案。",
    "history": "FDA Drugs@FDA 记录 NDA 017533 于 1975-06-04 首次批准。DailyMed 当前记录于 2025-12-01 更新，列示 0.5 mg 橙色刻痕片、1 mg 蓝色无刻痕片、2 mg 白色无刻痕片和对应 100 片瓶装。历史 KLONOPIN Wafers 口崩片、其他氯硝西泮产品以及其他市场不能并入这三种当前美国普通片。",
    "sourceDocuments": [
      {
        "id": "src_088098fd80958691",
        "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（2025-12-01 更新；SPL v6）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      {
        "id": "src_c226b8c9c6756f9d",
        "label": "FDA Drugs@FDA：KLONOPIN NDA 017533 产品与 RLD/RS 记录",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017533",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      {
        "id": "src_d4929922ecd19b2e",
        "label": "FDA：KLONOPIN 2023 美国处方信息（NDA 017533/S-062）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      }
    ],
    "applicationNumber": "FDA NDA 017533（KLONOPIN；clonazepam tablets）",
    "approvalTimeline": [
      {
        "date": "1975-06-04",
        "title": {
          "zh": "FDA 首次批准 KLONOPIN NDA 017533",
          "en": "FDA first approved KLONOPIN NDA 017533"
        },
        "detail": {
          "zh": "Drugs@FDA 将 KLONOPIN 氯硝西泮口服片与该美国首次批准日期相连；这是美国监管历史节点，不代表其他市场批准或今天的供应。",
          "en": "Drugs@FDA links KLONOPIN clonazepam oral tablets to this initial U.S. approval date. It is a U.S. regulatory-history node, not evidence of another market's approval or today's supply."
        },
        "source": {
          "id": "src_c226b8c9c6756f9d",
          "label": "FDA Drugs@FDA：KLONOPIN NDA 017533 产品记录与初始批准日期",
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017533",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      },
      {
        "date": "2025-12-01",
        "title": {
          "zh": "DailyMed 当前公开标签更新",
          "en": "Current DailyMed public label updated"
        },
        "detail": {
          "zh": "本页三种准确 100 片瓶装、外观、黑框警告和老人/多药阅读均以该公开标签为主要来源；标签更新时间不等于渠道库存。",
          "en": "The three exact 100-tablet bottles, appearance, boxed warning and older-adult/polypharmacy reading use this public label as the primary source. A label update date is not channel stock."
        },
        "source": {
          "id": "src_088098fd80958691",
          "label": "DailyMed（NLM）：KLONOPIN 当前美国公开标签（SPL v6）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "NDA 017533 当前公开产品记录与标签已建立",
          "en": "Current public product record and label established under NDA 017533"
        },
        "detail": {
          "zh": "0.5 mg、1 mg、2 mg 均列为处方 RLD；1 mg 另列为 RS。本页分别保存三种 NDC、100 片瓶装与标签图，但不声明任何渠道库存、真伪或个人适用性。",
          "en": "The 0.5 mg, 1 mg and 2 mg products are listed as prescription RLDs; 1 mg is also listed as RS. The page preserves each NDC, 100-tablet bottle and label image without claiming channel stock, authenticity or individual suitability."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本及其他市场",
          "en": "Mainland China, EU, Japan and other markets"
        },
        "status": {
          "zh": "现行品牌、批准、包装和参比关系待逐市场核验",
          "en": "Current brand, approval, pack and reference status not yet established market by market"
        },
        "detail": {
          "zh": "不从美国 KLONOPIN 商品名、NDA、RLD/RS、NDC、颜色或刻痕推定当地批准、供应、原研/参比关系、可售资格或可替代性。",
          "en": "No local approval, supply, originator/reference status, sale eligibility or interchangeability is inferred from the U.S. KLONOPIN name, NDA, RLD/RS status, NDC, colour or score."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "0.5 mg 有刻痕，能自己掰开或减量吗？",
          "en": "Can the scored 0.5 mg tablet be self-split or reduced?"
        },
        "answer": {
          "zh": "不能从刻痕直接得出个人结论。刻痕首先是这一准确产品的身份字段；是否可分割、怎样减量或停用必须由负责治疗的专业人员结合实际处方和包装制定。1 mg 与 2 mg 当前标签明确为无刻痕片。",
          "en": "A score does not decide an individual's plan. It first identifies the exact product. A treating professional must use the actual prescription and pack to decide whether division is appropriate and how reduction or stopping is handled. The current 1 mg and 2 mg tablets are unscored."
        }
      },
      {
        "question": {
          "zh": "能和 VALIUM、XANAX、阿片止痛药或酒一起用吗？",
          "en": "Can it be used with VALIUM, XANAX, an opioid or alcohol?"
        },
        "answer": {
          "zh": "网页不能决定个人联用。共同镇静作用可能叠加；KLONOPIN 与阿片类合用可造成深度镇静、呼吸抑制、昏迷和死亡。酒精、其他苯二氮䓬类和所有中枢抑制药都应随完整药单交给药师或医生核对。",
          "en": "A webpage cannot decide individual co-use. Sedating effects may add, and KLONOPIN with opioids can cause profound sedation, respiratory depression, coma and death. Alcohol, other benzodiazepines and all CNS depressants should be reviewed with the complete medicine list by a pharmacist or clinician."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": []
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/klonopin/",
    "en": "https://origindrug.com/en/drugs/klonopin/"
  },
  "limitations": [
    "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.",
    "Target-market current labels and official records must be checked separately."
  ]
}