{
  "id": "clonidine-transdermal-catapres-tts",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-15",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Catapres-TTS",
    "generic": "可乐定",
    "aliases": [
      "可乐定贴",
      "clonidine transdermal",
      "clonidine",
      "clonidine transdermal system"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "心血管",
    "sourceArchiveMarket": "美国公开监管档案",
    "dosageFormClass": "经皮给药系统（贴剂）",
    "dosageFormClassCode": "transdermal_system",
    "route": "经皮",
    "routeCode": "transdermal",
    "historicalApprovalEntry": "1984-10-10（FDA 橙皮书中 NDA 018891 的 Catapres-TTS 产品日期）",
    "archiveSponsorText": "Boehringer Ingelheim（FDA 历史资料所列）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-catapres-tts-1-clonidine-0-1mg-day-4-system-carton-8208920134",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-01-06 更新；说明书 2025-11 修订）",
        "en": "Current U.S. DailyMed public label (updated 6 Jan 2026; label revised Nov 2025)"
      },
      "dosageForm": {
        "zh": "CATAPRES-TTS-1 可乐定经皮给药系统",
        "en": "CATAPRES-TTS-1 clonidine transdermal system"
      },
      "route": {
        "zh": "经皮（标签产品身份字段）",
        "en": "transdermal (label product-identity field)"
      },
      "routeCodes": [
        "transdermal"
      ],
      "productCode": "NDC 82089-201-34",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "delivered_per_day_over_one_week",
      "primaryDisplay": {
        "zh": "每日标称释放可乐定 0.1 mg，持续一周；每个系统总含量 3.09 mg；面积 4.33 cm²；每盒 4 个系统及 4 个固定贴",
        "en": "Nominal clonidine delivery 0.1 mg per day for one week; 3.09 mg total per system; 4.33 cm²; four systems plus four adhesive covers per carton"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=catapres-TTS-1-carton.jpg&id=943373",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "可乐定（每日标称释放）",
            "en": "clonidine (nominal delivery per day)"
          },
          "value": 0.1,
          "unit": "mg",
          "basisCode": "delivered_per_day_over_one_week",
          "basisLabel": {
            "zh": "持续一周的每日标称释放量；不是个人贴数、时间或换药指令",
            "en": "nominal delivery per day for one week; not an individual patch count, timing or switching instruction"
          }
        },
        {
          "ingredient": {
            "zh": "可乐定（每个经皮系统总含量）",
            "en": "clonidine (total per transdermal system)"
          },
          "value": 3.09,
          "unit": "mg",
          "basisCode": "total_in_transdermal_system",
          "basisLabel": {
            "zh": "每个系统内总含量；不等于每日释放量",
            "en": "total amount in each system; not the amount delivered per day"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 4,
        "unit": {
          "zh": "个系统/盒，另附 4 个固定贴",
          "en": "systems per carton, plus 4 adhesive covers"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "棕褐色贴剂",
          "en": "tan patch"
        },
        "shape": {
          "zh": "矩形经皮系统，面积 4.33 cm²；固定贴不含活性药物",
          "en": "rectangular transdermal system, 4.33 cm²; adhesive cover contains no active medication"
        },
        "imprint": null,
        "scoreStatus": null,
        "patchAreaCm2": 4.33
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_078dfe139aa7e63f",
        "label": "DailyMed（NLM）：CATAPRES-TTS 可乐定经皮给药系统当前美国公开标签（Technomed；2026-01-06 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-catapres-tts-2-clonidine-0-2mg-day-4-system-carton-8208920234",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-01-06 更新；说明书 2025-11 修订）",
        "en": "Current U.S. DailyMed public label (updated 6 Jan 2026; label revised Nov 2025)"
      },
      "dosageForm": {
        "zh": "CATAPRES-TTS-2 可乐定经皮给药系统",
        "en": "CATAPRES-TTS-2 clonidine transdermal system"
      },
      "route": {
        "zh": "经皮（标签产品身份字段）",
        "en": "transdermal (label product-identity field)"
      },
      "routeCodes": [
        "transdermal"
      ],
      "productCode": "NDC 82089-202-34",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "delivered_per_day_over_one_week",
      "primaryDisplay": {
        "zh": "每日标称释放可乐定 0.2 mg，持续一周；每个系统总含量 6.19 mg；面积 8.67 cm²；每盒 4 个系统及 4 个固定贴",
        "en": "Nominal clonidine delivery 0.2 mg per day for one week; 6.19 mg total per system; 8.67 cm²; four systems plus four adhesive covers per carton"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "可乐定（每日标称释放）",
            "en": "clonidine (nominal delivery per day)"
          },
          "value": 0.2,
          "unit": "mg",
          "basisCode": "delivered_per_day_over_one_week",
          "basisLabel": {
            "zh": "持续一周的每日标称释放量；不是个人贴数、时间或换药指令",
            "en": "nominal delivery per day for one week; not an individual patch count, timing or switching instruction"
          }
        },
        {
          "ingredient": {
            "zh": "可乐定（每个经皮系统总含量）",
            "en": "clonidine (total per transdermal system)"
          },
          "value": 6.19,
          "unit": "mg",
          "basisCode": "total_in_transdermal_system",
          "basisLabel": {
            "zh": "每个系统内总含量；不等于每日释放量",
            "en": "total amount in each system; not the amount delivered per day"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 4,
        "unit": {
          "zh": "个系统/盒，另附 4 个固定贴",
          "en": "systems per carton, plus 4 adhesive covers"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "棕褐色贴剂",
          "en": "tan patch"
        },
        "shape": {
          "zh": "矩形经皮系统，面积 8.67 cm²；固定贴不含活性药物",
          "en": "rectangular transdermal system, 8.67 cm²; adhesive cover contains no active medication"
        },
        "imprint": null,
        "scoreStatus": null,
        "patchAreaCm2": 8.67
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_078dfe139aa7e63f",
        "label": "DailyMed（NLM）：CATAPRES-TTS 可乐定经皮给药系统当前美国公开标签（Technomed；2026-01-06 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-catapres-tts-3-clonidine-0-3mg-day-4-system-carton-8208920334",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-01-06 更新；说明书 2025-11 修订）",
        "en": "Current U.S. DailyMed public label (updated 6 Jan 2026; label revised Nov 2025)"
      },
      "dosageForm": {
        "zh": "CATAPRES-TTS-3 可乐定经皮给药系统",
        "en": "CATAPRES-TTS-3 clonidine transdermal system"
      },
      "route": {
        "zh": "经皮（标签产品身份字段）",
        "en": "transdermal (label product-identity field)"
      },
      "routeCodes": [
        "transdermal"
      ],
      "productCode": "NDC 82089-203-34",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "delivered_per_day_over_one_week",
      "primaryDisplay": {
        "zh": "每日标称释放可乐定 0.3 mg，持续一周；每个系统总含量 9.28 mg；面积 13 cm²；每盒 4 个系统及 4 个固定贴",
        "en": "Nominal clonidine delivery 0.3 mg per day for one week; 9.28 mg total per system; 13 cm²; four systems plus four adhesive covers per carton"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "可乐定（每日标称释放）",
            "en": "clonidine (nominal delivery per day)"
          },
          "value": 0.3,
          "unit": "mg",
          "basisCode": "delivered_per_day_over_one_week",
          "basisLabel": {
            "zh": "持续一周的每日标称释放量；不是个人贴数、时间或换药指令",
            "en": "nominal delivery per day for one week; not an individual patch count, timing or switching instruction"
          }
        },
        {
          "ingredient": {
            "zh": "可乐定（每个经皮系统总含量）",
            "en": "clonidine (total per transdermal system)"
          },
          "value": 9.28,
          "unit": "mg",
          "basisCode": "total_in_transdermal_system",
          "basisLabel": {
            "zh": "每个系统内总含量；不等于每日释放量",
            "en": "total amount in each system; not the amount delivered per day"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 4,
        "unit": {
          "zh": "个系统/盒，另附 4 个固定贴",
          "en": "systems per carton, plus 4 adhesive covers"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "棕褐色贴剂",
          "en": "tan patch"
        },
        "shape": {
          "zh": "矩形经皮系统，面积 13 cm²；固定贴不含活性药物",
          "en": "rectangular transdermal system, 13 cm²; adhesive cover contains no active medication"
        },
        "imprint": null,
        "scoreStatus": null,
        "patchAreaCm2": 13
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_078dfe139aa7e63f",
        "label": "DailyMed（NLM）：CATAPRES-TTS 可乐定经皮给药系统当前美国公开标签（Technomed；2026-01-06 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": null,
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=catapres-TTS-1-carton.jpg&id=943373",
    "alt": "CATAPRES-TTS-1 可乐定经皮给药系统在美国 DailyMed Technomed 公开标签中的 0.1 mg/日、4 个系统及 4 个固定贴包装图",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 公开标签（Technomed，2026-01 更新）",
    "presentation": "CATAPRES-TTS-1（clonidine transdermal system）0.1 mg/日、4 个系统及 4 个固定贴的纸盒图（NDC 82089-201-34；DailyMed 公开标签所列）。",
    "notice": "此为美国 DailyMed Technomed 公开标签中明确对应 CATAPRES-TTS-1、0.1 mg/日、4 个系统及 4 个固定贴的纸盒图，只帮助核对品牌、通用名、经皮给药系统、每日标示释放量、包装数量和来源；不用于鉴定真伪，也不证明 -2/-3 强度、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。",
    "source": {
      "id": "src_078dfe139aa7e63f",
      "label": "DailyMed（NLM）：CATAPRES-TTS 公开标签（Technomed，2026-01 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "Catapres-TTS 说明书放大阅读：贴剂面积、每日释放量与“多贴/剪开”不是可自行换算",
      "en": "Catapres-TTS label reading: patch area, stated daily release and “adding or cutting” are not self-conversion rules"
    },
    "summary": {
      "zh": "本模块以 FDA 2021 美国标签为阅读入口，帮助核对 Catapres-TTS、可乐定经皮给药系统、-1/-2/-3 标识、每周贴剂与标签所列每日释放量；它不决定贴几张、何时更换、如何从口服药转换或如何停止使用。",
      "en": "This module uses the 2021 U.S. FDA label as a reading entry point. It helps check Catapres-TTS, clonidine transdermal system, the -1/-2/-3 identifiers, the weekly system and the labelled daily release; it does not decide patch number, replacement timing, conversion from oral medicine or discontinuation."
    },
    "checks": [
      {
        "zh": "把 Catapres-TTS、可乐定经皮给药系统、-1/-2/-3、每周使用和 0.1/0.2/0.3 mg/日等标签信息作为同一组产品身份核对。这些是准确贴剂的标示信息，不是自行多贴、剪开、叠加、补贴或换成口服可乐定的换算规则。",
        "en": "Check Catapres-TTS, clonidine transdermal system, -1/-2/-3, weekly use and the 0.1/0.2/0.3 mg-per-day label information as one product-identity set. These identify the exact system; they are not self-conversion rules for adding, cutting, layering, replacing or changing to oral clonidine."
      },
      {
        "zh": "FDA 标签描述该贴剂为多层系统，并有控制释放的膜层。贴剂看起来松动、外观变化或感觉“药效不够”都不能用来推导自行裁剪、加大面积、补贴或改变使用方式；应带准确包装请药师或开方团队核对。",
        "en": "The FDA label describes a multilayer system with a rate-controlling membrane. A loose-looking system, a change in appearance or a feeling that it is “not enough” cannot be used to infer cutting, enlarging the area, adding another system or changing use; have the exact package reviewed by a pharmacist or prescribing team."
      },
      {
        "zh": "同为可乐定、都与血压相关，不能证明贴剂与口服制剂或其他降压药可自行合用、替换或突然停用。若同时有 β 受体阻滞剂、部分钙通道阻滞剂、镇静性药物、饮酒或其他慢病药，应把完整药单和实际产品交由专业人员核对。",
        "en": "Sharing clonidine or a blood-pressure context does not prove that a patch, an oral form or another antihypertensive can be self-combined, substituted or suddenly stopped. With a beta blocker, certain calcium-channel blockers, sedating medicines, alcohol or other chronic-care products, have professionals review the complete list and actual products."
      },
      {
        "zh": "贴敷处明显红肿、起疱或广泛皮疹，头晕、昏厥、心率异常相关不适，或 MRI、手术等特殊情形下对贴剂处理不确定时，应及时使用当地医疗和专业支持；本页不提供贴敷、移除或停用操作方案。",
        "en": "For marked redness, blistering or widespread rash at the application site, dizziness, fainting, symptoms related to an abnormal heart rate, or uncertainty about a patch around MRI, surgery or another special situation, use timely local medical and professional support; this page does not provide an application, removal or discontinuation plan."
      }
    ],
    "source": {
      "id": "src_1bfd095665169082",
      "label": "FDA：Catapres-TTS 2021 美国处方信息（NDA 018891）",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "可乐定怎样起作用：它作用于脑干 α 受体，降低交感神经输出",
      "en": "How clonidine works: it acts at brainstem alpha-adrenoreceptors and reduces sympathetic outflow"
    },
    "summary": {
      "zh": "FDA 标签说明可乐定刺激脑干 α 肾上腺素能受体，降低中枢交感神经传出，并可降低外周阻力、心率和血压。它帮助理解为何多种降压或影响心率的药物需要一起核对；它不能计算贴剂数量、每日释放量、口服转换或停用方式。",
      "en": "The FDA label explains that clonidine stimulates brainstem alpha-adrenoreceptors, reduces central sympathetic outflow, and can lower peripheral resistance, heart rate and blood pressure. This helps explain why blood-pressure or heart-rate medicines need review together; it cannot calculate patch number, daily release, oral conversion or discontinuation."
    },
    "checks": [
      {
        "zh": "“降低交感神经输出”是作用机制，不会让同一通用名的口服制剂与贴剂相互等同，也不能由此推导应贴几张、何时更换或是否可以自行停用。准确产品、处方和现行标签必须一并核对。",
        "en": "“Reducing sympathetic outflow” is a mechanism, not a basis for treating an oral form and a patch with the same generic name as equivalent, or for deriving patch number, replacement timing or self-discontinuation. The exact product, prescription and current label must be checked together."
      },
      {
        "zh": "该机制也解释了为什么 β 受体阻滞剂、部分钙通道阻滞剂和其他影响心率或血压的产品不能只按药名判断能否并用、替换或轮换。多药情形应交由药师或开方团队逐项复核。",
        "en": "This mechanism also helps explain why beta blockers, certain calcium-channel blockers and other products affecting heart rate or blood pressure cannot be judged by name alone for combination, substitution or alternation. Multiple medicines need item-by-item review by a pharmacist or prescribing team."
      },
      {
        "zh": "困倦、头晕、低心率相关不适、血压变化或新的皮肤反应都不能从机制页面自行处理。若出现急性不适或考虑改变、移除任何贴剂，应及时使用当地专业支持，而不是从药理名词推导操作。",
        "en": "Drowsiness, dizziness, symptoms related to a low heart rate, blood-pressure changes or a new skin reaction cannot be self-managed from a mechanism page. With an acute concern or a plan to change or remove any system, use timely local professional support rather than derive an action from pharmacology terms."
      }
    ],
    "source": {
      "id": "src_1bfd095665169082",
      "label": "FDA：Catapres-TTS 2021 美国处方信息（临床药理）",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "Catapres-TTS",
      "generic": "可乐定",
      "dosageFormClass": "经皮给药系统（贴剂）"
    },
    "labelSource": {
      "id": "src_1bfd095665169082",
      "label": "FDA：Catapres-TTS 公开标签",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_1bfd095665169082",
          "label": "FDA：Catapres-TTS 公开标签",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        },
        "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": "2026-08-20",
        "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": "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": "2026-08-20",
      "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": "FDA 公开资料显示的经皮给药系统档案示例；贴剂不能按通用名与口服或注射制剂直接等同。",
    "history": "FDA 橙皮书历史清单将 NDA 018891 的 Catapres-TTS 产品日期列为 1984-10-10；另有 1996 年补充申请资料包。二者均为历史文件，不代表当前标签、规格、持有人、供应或可得性；任何市场的当前记录必须另行核验。",
    "sourceDocuments": [
      {
        "id": "src_92083977907c29eb",
        "label": "FDA：橙皮书历史清单中的 Catapres-TTS（NDA 018891；产品日期 1984-10-10）",
        "url": "https://www.fda.gov/media/145882/download",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "regulatory_reference",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_d9e2d89cb3871208",
        "label": "FDA：Catapres-TTS 补充申请资料包",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.htm",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "approval_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_1bfd095665169082",
        "label": "FDA：Catapres-TTS 公开标签",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_5ed30b676fbb9773",
        "label": "FDA Drugs@FDA",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "official_lookup_entry",
        "documentKind": "regulatory_lookup",
        "market": "US",
        "accessStatus": "public_access_requires_interaction",
        "accessMode": "interactive_lookup",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      }
    ],
    "applicationNumber": "NDA 018891（另列 1996 年 S15 补充申请资料）",
    "approvalTimeline": [
      {
        "date": "1984-10-10",
        "title": {
          "zh": "FDA 橙皮书历史产品日期",
          "en": "FDA Orange Book historical product date"
        },
        "detail": {
          "zh": "FDA 橙皮书历史清单将 NDA 018891 的 Catapres-TTS 产品日期列为 1984-10-10。该历史清单不代表当前标签、规格、持有人、供应或其他市场状态。",
          "en": "An FDA Orange Book historical listing gives 10 Oct 1984 as the product date for Catapres-TTS under NDA 018891. This historical listing does not establish current labelling, strength, holder, supply or another-market status."
        },
        "source": {
          "id": "src_92083977907c29eb",
          "label": "FDA: Orange Book historical listing for Catapres-TTS (NDA 018891; product date 10 Oct 1984)",
          "url": "https://www.fda.gov/media/145882/download",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "regulatory_reference",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "1996-09-06",
        "title": {
          "zh": "FDA 补充申请资料包节点",
          "en": "FDA supplement-package entry"
        },
        "detail": {
          "zh": "本页链接的 FDA Catapres-TTS 补充申请资料包记录 NDA 018891-S15 与 1996-09-06 节点。它不代表初始批准或当前产品状态。",
          "en": "The linked FDA Catapres-TTS supplement package records NDA 018891-S15 and a 6 Sep 1996 entry. It does not represent initial approval or current product status."
        },
        "source": {
          "id": "src_d9e2d89cb3871208",
          "label": "FDA: Catapres-TTS supplement package",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.htm",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "approval_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2021",
        "title": {
          "zh": "FDA 经皮给药系统标签档案",
          "en": "FDA transdermal-system label archive"
        },
        "detail": {
          "zh": "本页链接 FDA 2021 Catapres-TTS 标签档案，用于区分经皮系统与口服或注射制剂；现行标签和规格须以目标市场文件独立核对。",
          "en": "The linked 2021 FDA Catapres-TTS label archive helps distinguish a transdermal system from oral or injectable presentations; the current label and strength require independent target-market review."
        },
        "source": {
          "id": "src_1bfd095665169082",
          "label": "FDA: Catapres-TTS label archive",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "已链接公开档案",
          "en": "Public archive linked"
        },
        "detail": {
          "zh": "仅对应本页列出的 FDA 补充申请及标签档案。",
          "en": "Only the FDA supplement package and label archive listed on this page are linked."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本",
          "en": "Mainland China, EU, Japan"
        },
        "status": {
          "zh": "待逐项建立市场记录",
          "en": "Market record not established"
        },
        "detail": {
          "zh": "不从美国历史文件推定当地批准、持有人、贴剂规格、供应或可售资格。",
          "en": "No local approval, holder, patch strength, supply or sale-eligibility conclusion is inferred from U.S. historical material."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "为什么贴剂不能只按通用名核验？",
          "en": "Why cannot a patch be checked by generic name alone?"
        },
        "answer": {
          "zh": "经皮系统的释放设计、规格、材料和标签版本都需单独核对；照片或通用名不能建立与口服或注射剂的等同性。",
          "en": "A transdermal system’s release design, strength, materials and label version each need separate review; a photo or generic name cannot establish equivalence with oral or injectable products."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/clonidine-transdermal-catapres-tts/",
    "en": "https://origindrug.com/en/drugs/clonidine-transdermal-catapres-tts/"
  },
  "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."
  ]
}