{ "id": "hytrin-terazosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "HYTRIN", "generic": "盐酸特拉唑嗪胶囊", "aliases": [ "Hytrin", "terazosin", "terazosin hydrochloride", "特拉唑嗪", "盐酸特拉唑嗪", "高特灵", "HYTRIN", "terazosin capsules", "盐酸特拉唑嗪胶囊", "NDA 019057", "NDA 020347", "ANDA 074823", "24689-001-01", "24689-002-01", "24689-003-01", "24689-004-01" ], "marketBrandNames": [ { "name": "HYTRIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_originator_rld_discontinued", "note": { "zh": "NDA 019057（片）与 NDA 020347（胶囊）；历史 1、2、5、10 mg，现均停市。", "en": "NDA 019057 (tablets) and NDA 020347 (capsules); historical 1, 2, 5 and 10 mg products, now discontinued." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "FDA 2025 审评确认 HYTRIN 片 NDA 019057 于 1987-08-07 首次批准，HYTRIN 胶囊 NDA 020347 于 1994-12-14 批准；历史 1、2、5、10 mg 产品均已停市，监管记录说明并非因安全性或有效性撤回。页面四张准确图片来自 ANDA 074823 当前通用药，绝不能当作 HYTRIN 原品牌外观、实时库存或真伪证明。", "dosageFormClass": "历史 HYTRIN 包括普通口服片与胶囊；当前页面的准确包装比较项是盐酸特拉唑嗪通用药胶囊。TEZRULY 是 1 mg/mL 口服液，剂型、浓度、申请号和量取方式不同，不能按共同成分自行换算或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（美国首次批准 HYTRIN 片；1994 批准胶囊）", "archiveSponsorText": "Abbott（HYTRIN 历史 NDA 申请人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "HYTRIN", "Hytrin terazosin", "盐酸特拉唑嗪胶囊", "特拉唑嗪胶囊", "高特灵" ], "excludedProductCues": [ "TEZRULY", "terazosin oral solution", "特拉唑嗪口服液", "FLOMAX", "tamsulosin", "RAPAFLO", "silodosin", "UROXATRAL", "alfuzosin", "CARDURA", "doxazosin", "MINIPRESS", "prazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-terazosin-1mg-100-capsule-bottle-ndc-2468900101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-001-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 1 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 1 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-01.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 1, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-terazosin-2mg-100-capsule-bottle-ndc-2468900201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-002-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 2 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 2 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-02.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 2, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-terazosin-5mg-100-capsule-bottle-ndc-2468900301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-003-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 5 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 5 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-03.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-terazosin-10mg-100-capsule-bottle-ndc-2468900401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-004-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 10 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 10 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-04.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-terazosin-1mg-100-capsule-bottle-ndc-2468900101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-01.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "alt": "盐酸特拉唑嗪 1 mg、NDC 24689-001-01、100 粒瓶装的当前通用药 DailyMed 标签面板；不是 HYTRIN 原品牌包装", "archiveMarket": "美国", "labelVersion": "DailyMed 当前通用药标签（2026-08-08 更新）", "presentation": "当前通用药准确包装比较：1、2、5、10 mg，均为 100 粒瓶装；四个 NDC 必须分开核对。", "notice": "图像仅对应 ANDA 074823 当前通用药，不能用于想象 HYTRIN 历史原品牌外观、确认实时有货，也不用于鉴定真伪。", "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "特拉唑嗪说明书放大阅读：先分清每粒 mg、整瓶粒数与首次/恢复使用风险", "en": "Enlarged terazosin label: separate per-capsule mg, bottle count and first/restart risk" }, "summary": { "zh": "1、2、5、10 mg 是每粒特拉唑嗪标示量；100 Capsules 是整瓶粒数。说明书对首次使用、增加强度以及中断数日后恢复时的明显降压、体位性低血压与晕厥作出重点警示；网页不把标签中的剂量段落转写成个人方案。", "en": "The 1, 2, 5 and 10 mg figures are labelled terazosin per capsule; 100 Capsules is the bottle count. The label prominently warns about marked blood-pressure lowering, orthostatic hypotension and syncope when starting, increasing a strength or restarting after several days; the site does not turn dosing text into an individual plan." }, "checks": [ { "zh": "老人、有跌倒史、夜间起身或同时使用其他降压药者，应把完整药单、近期是否中断和症状交给医生或药师核对。不要自行恢复、加量、错开或停掉一盒。", "en": "Older adults, people with falls, those rising at night or using another blood-pressure medicine should have the full list, recent interruption and symptoms reviewed. Do not self-restart, increase, separate or stop a pack." }, { "zh": "说明书记录特拉唑嗪与 PDE-5 抑制剂同用时出现低血压。CIALIS、VIAGRA 等出现在同一药单时，不要自己安排时间差或减量。", "en": "The label reports hypotension with PDE-5 inhibitors. If CIALIS, VIAGRA or a similar medicine is on the same list, do not self-design spacing or dose reductions." }, { "zh": "白内障手术前要主动告诉眼科团队现在或过去使用过特拉唑嗪/其他 α1 阻滞剂；标签指出自行停药未显示获益。", "en": "Before cataract surgery, tell the eye team about current or previous terazosin/other alpha-1 blocker use; the label says self-stopping has not shown benefit." }, { "zh": "晕厥或跌倒受伤需要及时医疗评估；持续数小时的疼痛勃起属于罕见但紧急的标签警示，应立即联系急诊服务。", "en": "Syncope or a fall with injury needs timely medical assessment. A painful erection lasting for hours is a rare but urgent labelled warning requiring immediate emergency care." } ], "source": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "特拉唑嗪怎样起作用：阻断 α1 肾上腺素能受体，影响下尿路平滑肌与血管阻力", "en": "How terazosin works: alpha-1 adrenergic blockade affects lower-urinary-tract smooth muscle and vascular resistance" }, "summary": { "zh": "说明书解释，特拉唑嗪可放松前列腺与膀胱开口处平滑肌，帮助改善相关尿路症状；其血管作用也可降低血压。它不会缩小前列腺，也不治疗前列腺癌；相似症状仍需专业评估。", "en": "The label explains that terazosin relaxes smooth muscle in the prostate and bladder outlet, helping related urinary symptoms; its vascular effect can also lower blood pressure. It does not shrink the prostate or treat prostate cancer, and similar symptoms still need professional evaluation." }, "checks": [ { "zh": "HYTRIN、FLOMAX、RAPAFLO、UROXATRAL、CARDURA 与 MINIPRESS 不是同一种药。共同的 α 阻滞机制不建立 mg 换算、轮换、叠加或替换规则。", "en": "HYTRIN, FLOMAX, RAPAFLO, UROXATRAL, CARDURA and MINIPRESS are not one medicine. Related alpha blockade creates no milligram conversion, alternation, combination or substitution rule." }, { "zh": "HYTRIN 历史片剂、历史胶囊、当前通用药胶囊与 TEZRULY 口服液是不同准确产品；剂型和数字必须与手中药盒、处方和目标市场现行说明书一起核对。", "en": "Historical HYTRIN tablets, historical HYTRIN capsules, current generic capsules and TEZRULY oral solution are different exact products. Form and figures must be checked with the pack, prescription and current target-market label." }, { "zh": "作用机理不能替代血压、完整药单、跌倒史和个体评估，也不能根据夜尿或排尿困难自行判断该用哪一种药。", "en": "Mechanism does not replace blood pressure, the complete medicine list, fall history and individual assessment, or identify a medicine from nocturia or urinary difficulty alone." } ], "source": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "HYTRIN", "generic": "盐酸特拉唑嗪胶囊", "dosageFormClass": "历史 HYTRIN 包括普通口服片与胶囊；当前页面的准确包装比较项是盐酸特拉唑嗪通用药胶囊。TEZRULY 是 1 mg/mL 口服液，剂型、浓度、申请号和量取方式不同，不能按共同成分自行换算或替换。" }, "labelSource": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_272c697ae8339dce", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-02", "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": "HYTRIN 是特拉唑嗪的美国历史品牌档案。1、2、5、10 mg 是每粒含量，100 Capsules 是整瓶粒数，不是个人粒数或恢复用药方案。老人和多药使用者尤其要核对首次使用或中断后恢复时的突然降压、头晕、晕厥和跌倒，以及其他降压药、PDE-5 抑制剂和白内障手术信息；网页不替个人决定规格、时间、加量或换药。", "history": "FDA 资料显示，HYTRIN 片 NDA 019057 于 1987-08-07 获批，1993-09-29 增加良性前列腺增生相关批准，HYTRIN 胶囊 NDA 020347 于 1994-12-14 获批。片剂与胶囊后续均停市；FDA 审评引用的联邦公报结论为并非因安全性或有效性原因撤回。历史身份与当前可见通用药包装必须分开。", "sourceDocuments": [ { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_272c697ae8339dce", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 019057 / NDA 020347", "approvalTimeline": [ { "date": "1987-08-07", "title": { "zh": "HYTRIN 片首次获 FDA 批准", "en": "FDA first approved HYTRIN tablets" }, "detail": { "zh": "NDA 019057；历史 1、2、5、10 mg 片。", "en": "NDA 019057; historical 1, 2, 5 and 10 mg tablets." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1993-09-29", "title": { "zh": "增加 BPH 相关批准", "en": "BPH-related approval added" }, "detail": { "zh": "FDA 2025 审评记录的历史里程碑。", "en": "Historical milestone recorded in the 2025 FDA review." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1994-12-14", "title": { "zh": "HYTRIN 胶囊获 FDA 批准", "en": "FDA approved HYTRIN capsules" }, "detail": { "zh": "NDA 020347；历史 1、2、5、10 mg 胶囊。", "en": "NDA 020347; historical 1, 2, 5 and 10 mg capsules." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 HYTRIN", "en": "U.S. HYTRIN" }, "status": { "zh": "历史原研/RLD 已停市", "en": "Historical originator/RLD, discontinued" }, "detail": { "zh": "FDA 审评说明停市并非安全性或有效性原因；不表示现在有货。", "en": "FDA review states discontinuation was not for safety or effectiveness; this does not indicate current stock." } }, { "market": { "zh": "美国通用药比较项", "en": "U.S. generic comparator" }, "status": { "zh": "当前公开标签与包装面板", "en": "Current public label and package panels" }, "detail": { "zh": "ANDA 074823；1、2、5、10 mg，100 粒瓶装；不是 HYTRIN 原品牌。", "en": "ANDA 074823; 1, 2, 5 and 10 mg in 100-capsule bottles; not original-brand HYTRIN." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "图片里的瓶子是 HYTRIN 原研药吗？", "en": "Are the pictured bottles original-brand HYTRIN?" }, "answer": { "zh": "不是。页面将它们明确标为当前通用药比较项，来自 ANDA 074823。HYTRIN 历史身份由 FDA 审评文件证明，但本页没有把当前通用药图片冒充历史原品牌外观。", "en": "No. They are explicitly marked as current generic comparators under ANDA 074823. FDA review supports HYTRIN's historical identity, but the site does not pass current generic images off as historical originator appearance." } }, { "question": { "zh": "停了几天，能按以前的规格直接恢复吗？", "en": "Can I restart the old strength after missing several days?" }, "answer": { "zh": "网页不能给出个人恢复方案。标签特别提示中断数日后恢复可能再次出现明显降压与晕厥风险；请带准确药盒、停药天数、血压、跌倒/头晕情况和完整药单联系开方团队或药师。", "en": "The site cannot provide an individual restart plan. The label specifically warns that restarting after several days can again cause marked blood-pressure lowering and syncope; contact the prescriber or pharmacist with the exact pack, interruption duration, blood pressure, falls/dizziness and full medicine list." } }, { "question": { "zh": "能换成 FLOMAX、RAPAFLO 或 CARDURA 吗？", "en": "Can it be switched to FLOMAX, RAPAFLO or CARDURA?" }, "answer": { "zh": "不能从相似用途或共同 α 阻滞机制作出这种结论。成分、剂型、强度、申请号和说明书不同，不能按 mg 自行一比一换算、轮换或叠加。", "en": "That conclusion cannot be made from a similar use or alpha-blocking mechanism. Ingredients, forms, strengths, applications and labels differ, so do not self-convert, alternate or combine them milligram for milligram." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/hytrin-terazosin/", "en": "https://origindrug.com/en/drugs/hytrin-terazosin/" }, "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." ] }