{ "id": "detrol-la", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DETROL LA", "generic": "酒石酸托特罗定缓释胶囊", "aliases": [ "Detrol LA", "tolterodine tartrate extended release", "tolterodine ER", "tolterodine LA", "酒石酸托特罗定缓释胶囊", "托特罗定缓释胶囊", "tolterodine", "tolterodine tartrate", "tolterodine extended release", "酒石酸托特罗定", "NDA 021228", "58151-103-93", "58151-104-93" ], "marketBrandNames": [ { "name": "DETROL LA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record_with_dated_package_panels", "note": { "zh": "NDA 021228；2 mg 与 4 mg 为当前 Orange Book 处方 RLD，4 mg 同时为 RS；所示 30 粒瓶装 NDC 的营销终止日均为 2026-07-31。", "en": "NDA 021228; 2 mg and 4 mg are current Orange Book prescription RLD products, with 4 mg also the RS; both displayed 30-capsule NDCs have a marketing end date of 31 Jul 2026." }, "source": { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国：FDA Orange Book 当前数据将 DETROL LA 2 mg 与 4 mg 缓释胶囊列为处方 RLD，并将 4 mg 列为 RS。DailyMed SPL v4 提供两个 30 粒瓶装准确面板，但所示 NDC 58151-103-93 与 58151-104-93 的营销终止日均为 2026-07-31；因此页面只把图片作为有日期包装档案，不解释为当前库存、可购买或仍在营销。", "dosageFormClass": "酒石酸托特罗定缓释口服胶囊：每粒 2 mg 或 4 mg；标签要求用液体整粒吞服；不是托特罗定普通片、非索罗定缓释片或其他膀胱药", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000-12-22（美国 FDA 初始批准）", "archiveSponsorText": "Upjohn US 2 LLC（FDA Orange Book 当前申请主体）；Viatris Specialty LLC（所引 DailyMed 标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DETROL immediate release", "tolterodine immediate-release tablet", "托特罗定普通片", "fesoterodine", "TOVIAZ", "other tolterodine brands", "其他厂牌托特罗定" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-detrol-la-tolterodine-tartrate-2mg-30-capsule-bottle-ndc-5815110393", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2025-06-09 发布；处方信息 2023-03 修订；该 NDC 营销终止日 2026-07-31）", "en": "DailyMed SPL v4 (published 9 Jun 2025; prescribing information revised Mar 2023; this NDC marketing end date 31 Jul 2026)" }, "dosageForm": { "zh": "DETROL LA 酒石酸托特罗定缓释口服胶囊", "en": "DETROL LA tolterodine tartrate extended-release oral capsule" }, "route": { "zh": "口服（完整缓释胶囊身份字段）", "en": "oral (intact extended-release capsule identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-103-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒酒石酸托特罗定 2 mg；30 粒瓶装；该包装记录营销终止日为 2026-07-31", "en": "Tolterodine tartrate 2 mg per capsule; 30-capsule bottle; this package record has a marketing end date of 31 Jul 2026" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&archiveid=894296", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸托特罗定", "en": "tolterodine tartrate" }, "value": 2, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、使用频率、加减量或换药指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_package_record_marketing_ended_2026_07_31", "marketingStartDate": null, "marketingEndDate": "2026-07-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝绿色，白色数字 2", "en": "blue-green with a white numeral 2" }, "shape": { "zh": "胶囊，约 14 mm；无刻痕；标签要求整粒吞服", "en": "capsule, approximately 14 mm; unscored; label says to swallow whole" }, "imprint": "2", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-detrol-la-tolterodine-tartrate-4mg-30-capsule-bottle-ndc-5815110493", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2025-06-09 发布；处方信息 2023-03 修订；该 NDC 营销终止日 2026-07-31）", "en": "DailyMed SPL v4 (published 9 Jun 2025; prescribing information revised Mar 2023; this NDC marketing end date 31 Jul 2026)" }, "dosageForm": { "zh": "DETROL LA 酒石酸托特罗定缓释口服胶囊", "en": "DETROL LA tolterodine tartrate extended-release oral capsule" }, "route": { "zh": "口服（完整缓释胶囊身份字段）", "en": "oral (intact extended-release capsule identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-104-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒酒石酸托特罗定 4 mg；30 粒瓶装；该包装记录营销终止日为 2026-07-31", "en": "Tolterodine tartrate 4 mg per capsule; 30-capsule bottle; this package record has a marketing end date of 31 Jul 2026" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=894296", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸托特罗定", "en": "tolterodine tartrate" }, "value": 4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、使用频率、加减量或换药指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_package_record_marketing_ended_2026_07_31", "marketingStartDate": null, "marketingEndDate": "2026-07-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色，白色数字 4", "en": "blue with a white numeral 4" }, "shape": { "zh": "胶囊，约 16 mm；无刻痕；标签要求整粒吞服", "en": "capsule, approximately 16 mm; unscored; label says to swallow whole" }, "imprint": "4", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-detrol-la-tolterodine-tartrate-4mg-30-capsule-bottle-ndc-5815110493", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=894296", "alt": "DETROL LA 酒石酸托特罗定缓释胶囊 4 mg、30 粒、NDC 58151-104-93 的美国 DailyMed 有日期包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4；2025-06-09 发布；该 NDC 营销终止日 2026-07-31", "presentation": "DETROL LA 酒石酸托特罗定缓释胶囊 4 mg，30 粒瓶装，NDC 58151-104-93。", "notice": "此图只对应所引 DailyMed 有日期标签中的 4 mg、30 粒瓶装；该 NDC 的营销终止日为 2026-07-31。它不用于鉴定真伪，也不证明当前库存、可购买、其他包装、2 mg、普通片、其他厂牌、其他市场或个人适用性。", "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DETROL LA 说明书放大阅读：整粒吞服，先核对抗胆碱负担和完整药单", "en": "DETROL LA label reading: swallow the capsule whole and review anticholinergic burden with the complete medicine list" }, "summary": { "zh": "标签要求用液体整粒吞服；如果不能吞下胶囊，应告知医生。网页不把 2 mg、4 mg 变成个人选择题，也不把‘缓释胶囊’解释成可以自行打开、分粒、压碎或换成普通片。", "en": "The label says to swallow the capsule whole with liquid and tell the doctor if the capsule cannot be swallowed. The site does not turn 2 mg and 4 mg into an individual choice or interpret ‘extended-release capsule’ as permission to open, divide, crush or replace it with an immediate-release tablet." }, "checks": [ { "zh": "2 mg 与 4 mg 是每粒标签量，30 粒是瓶内数量。两个 2 mg 在算术上等于 4 mg，也不能据此自行拼粒、加减量、替换 4 mg 产品、补服或照搬他人的处方。", "en": "2 mg and 4 mg are labelled amounts per capsule, while 30 is the bottle count. Although two 2 mg numbers add to 4 mg, that does not permit self-assembling capsules, changing an amount, replacing a 4 mg product, making up a dose or copying another person's prescription." }, { "zh": "用液体整粒吞服。标签没有把胶囊外观、无刻痕或‘缓释’写成可自行打开、嚼碎、压碎、分装或拌食的许可；吞咽困难时应带准确药盒和处方让药师或开方团队核对可行方案。", "en": "Swallow the capsule whole with liquid. The label does not turn capsule appearance, lack of a score or ‘extended release’ into permission to open, chew, crush, divide or sprinkle it. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber for an appropriate plan." }, { "zh": "口干、便秘、腹痛、视物模糊、头晕或嗜睡是标签提示的重要不良反应线索。老人、认知功能下降者或有跌倒风险者，以及同时使用安眠药、抗过敏药、止吐药、膀胱药或其他抗胆碱药者，应优先核对完整药单。", "en": "Dry mouth, constipation, abdominal pain, blurred vision, dizziness or drowsiness are important label adverse-effect cues. Older adults, people with cognitive impairment or fall risk, and those using sleeping, allergy, nausea, bladder or other anticholinergic medicines need priority review of the complete medicine list." }, { "zh": "尿潴留、胃潴留和未控制的闭角型青光眼属于标签禁忌；胃肠梗阻或动力下降、重症肌无力、肝肾功能问题和 QT 间期延长史也需要主动说明。", "en": "Urinary retention, gastric retention and uncontrolled narrow-angle glaucoma are labelled contraindications. Gastrointestinal obstruction or reduced motility, myasthenia gravis, liver or kidney impairment and a history of QT prolongation also need to be disclosed." }, { "zh": "面部、嘴唇、舌或咽喉肿胀、呼吸困难、上气道阻塞或血压下降需要立即急救。严重腹胀、不能排便排气、不能排尿、晕厥或明显意识变化也应尽快获得医疗评估。", "en": "Swelling of the face, lips, tongue or throat, breathing difficulty, upper-airway obstruction or a fall in blood pressure needs emergency help. Severe distension, inability to pass stool or gas, inability to urinate, fainting or marked mental-status change also needs prompt medical assessment." }, { "zh": "强 CYP3A4 抑制剂、其他抗胆碱药及某些影响 QT 的药可能改变风险。标签示例包括克拉霉素、利托那韦、酮康唑和部分抗心律失常药；网页不据此生成个人减量或错开时间表。", "en": "Potent CYP3A4 inhibitors, other anticholinergics and some QT-related medicines may change risk. Label examples include clarithromycin, ritonavir, ketoconazole and certain antiarrhythmics; the site does not generate an individual reduction or time-separation schedule from this information." } ], "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "DETROL LA 怎样起作用：抗毒蕈碱作用与缓释胶囊是两层不同概念", "en": "How DETROL LA works: antimuscarinic action and an extended-release capsule are two different concepts" }, "summary": { "zh": "托特罗定及其活性代谢物作用于毒蕈碱受体相关通路，帮助降低膀胱不自主收缩；缓释胶囊则描述药物释放方式。机制解释产品设计，不证明某个老人一定适合，也不能从尿频、年龄或毫克数生成个人方案。", "en": "Tolterodine and its active metabolite act through muscarinic-receptor pathways related to bladder contraction, while the extended-release capsule describes how medicine is released. Mechanism explains product design; it does not prove suitability for an older person or generate an individual plan from urinary frequency, age or milligrams." }, "checks": [ { "zh": "同一作用路径也可能影响唾液、肠道、眼睛、排尿和中枢神经系统，因此不能只把它看成‘膀胱药’，忽略便秘、视物模糊、嗜睡、意识变化和完整药单。", "en": "The same pathway can also affect saliva, bowel, eyes, urination and the central nervous system, so a ‘bladder medicine’ label must not hide constipation, blurred vision, drowsiness, mental-status change or the complete medicine list." }, { "zh": "DETROL LA、DITROPAN XL、VESIcare、TOVIAZ 与 MYRBETRIQ 是不同产品；相同用途不表示成分、受体作用、缓释结构、相互作用或不良反应相同，不能按毫克数自行叠加、轮换或替换。", "en": "DETROL LA, DITROPAN XL, VESIcare, TOVIAZ and MYRBETRIQ are different products. A shared use does not make their ingredients, receptor actions, release designs, interactions or adverse effects the same, and does not permit self-combination, alternation or substitution by milligrams." }, { "zh": "全基因筛查不是本站为这种选择设定的通用前提。实际核对更需要准确诊断和目标、认知与跌倒风险、排尿和肠道情况、青光眼与心律史、肝肾功能及全部用药。", "en": "Whole-genome screening is not a universal prerequisite set by this site for this choice. Review more directly requires the exact diagnosis and goals, cognition and fall risk, urinary and bowel status, glaucoma and rhythm history, liver and kidney function, and all medicines." } ], "source": { "id": "src_d8de723fa4211d33", "label": "FDA：DETROL LA 酒石酸托特罗定缓释胶囊有日期处方信息（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DETROL LA", "generic": "酒石酸托特罗定缓释胶囊", "dosageFormClass": "酒石酸托特罗定缓释口服胶囊：每粒 2 mg 或 4 mg；标签要求用液体整粒吞服；不是托特罗定普通片、非索罗定缓释片或其他膀胱药" }, "labelSource": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_d8de723fa4211d33", "label": "FDA：DETROL LA 酒石酸托特罗定缓释胶囊有日期处方信息（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "2026-08-29", "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": "DETROL LA 是酒石酸托特罗定缓释胶囊的美国品牌档案。普通人最需要先看懂三件事：2 mg、4 mg 是每粒强度，不是一次吃几粒；标签要求整粒吞服，吞咽困难不能自行打开、咬碎或改换普通片；它具有抗毒蕈碱作用，老人出现口干、便秘、尿不出、视物模糊、头晕、嗜睡或意识变化时，应把完整药单交给药师或开方团队核对。本页不提供个人剂量、停药、换药或联用方案。", "history": "FDA 原始资料将 DETROL LA 2 mg 与 4 mg 缓释胶囊的初始美国批准日期列为 2000-12-22。当前 Orange Book 保留两个处方 RLD 产品，并将 4 mg 列为 RS。DailyMed SPL v4 于 2025-06-09 发布、处方信息修订于 2023-03；所示两个 30 粒瓶装 NDC 的营销终止日为 2026-07-31。页面保留其来源和版本，不把历史或有日期包装写成实时供应。", "sourceDocuments": [ { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d8de723fa4211d33", "label": "FDA：DETROL LA 酒石酸托特罗定缓释胶囊有日期处方信息（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_807fb7308d2969bc", "label": "FDA：DETROL LA NDA 021228 原始批准标签（2000）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021228（DETROL LA / tolterodine tartrate extended-release capsules）", "approvalTimeline": [ { "date": "2000-12-22", "title": { "zh": "FDA 初始批准 DETROL LA 2 mg 与 4 mg", "en": "FDA initially approved DETROL LA 2 mg and 4 mg" }, "detail": { "zh": "FDA 原始标签与当前 Orange Book 将两个缓释胶囊规格与 NDA 021228 相连。", "en": "The FDA original label and current Orange Book link both extended-release capsule strengths to NDA 021228." }, "source": { "id": "src_807fb7308d2969bc", "label": "FDA：DETROL LA NDA 021228 原始批准标签（2000）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-03", "title": { "zh": "所引 DailyMed 处方信息修订节点", "en": "Cited DailyMed prescribing-information revision" }, "detail": { "zh": "标签提供整粒吞服、抗胆碱中枢作用、尿潴留、胃肠道、青光眼、QT 与相互作用等阅读边界。", "en": "The label supports whole-capsule, anticholinergic CNS, urinary-retention, gastrointestinal, glaucoma, QT and interaction reading boundaries." }, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-06-09", "title": { "zh": "DailyMed SPL v4 发布", "en": "DailyMed SPL v4 published" }, "detail": { "zh": "该版本提供 2 mg 与 4 mg、30 粒瓶装准确面板及 NDC；页面同时保留其包装营销终止日期。", "en": "This version provides exact 2 mg and 4 mg 30-capsule bottle panels and NDCs, while retaining their package marketing end dates." }, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "复核美国当前 Orange Book 身份", "en": "Current U.S. Orange Book identity reviewed" }, "detail": { "zh": "2 mg 与 4 mg 均列为处方 RLD，4 mg 同时为 RS。该复核不证明任何药房当前有货。", "en": "Both 2 mg and 4 mg are listed as prescription RLD products, with 4 mg also the RS. This review does not establish current pharmacy stock." }, "source": { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 Orange Book RLD 身份；所示两个包装 NDC 已过营销终止日", "en": "Current Orange Book RLD identity; both displayed package NDCs are past their marketing end date" }, "detail": { "zh": "准确图像仍用于核对有日期的品牌、通用名、每粒强度、NDC 和包装数量；不证明当前供应、购买资格、真伪或个人适用性。", "en": "Exact images remain useful for checking the dated brand, generic name, per-capsule strength, NDC and pack count; they do not establish current supply, purchase eligibility, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌、NDA、RLD、通用名、毫克数或包装颜色推定当地商品名、批准、包装、供应或可替代性。", "en": "No local brand, approval, pack, supply or interchangeability is inferred from the U.S. brand, NDA, RLD identity, generic name, milligrams or package colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "4 mg 胶囊可以打开倒一半，变成 2 mg 吗？", "en": "Can a 4 mg capsule be opened and half used as 2 mg?" }, "answer": { "zh": "不能自行这样做。标签要求用液体整粒吞服；胶囊内的缓释结构和粉粒外观不能作为目测分半工具。需要调整时应核对准确处方、现有产品和吞咽问题。", "en": "Do not do this yourself. The label says to swallow the capsule whole with liquid; the extended-release contents and their appearance are not a visual half-measure. Any adjustment requires review of the exact prescription, available product and swallowing concern." } }, { "question": { "zh": "和 DITROPAN XL、VESIcare 或 MYRBETRIQ 能一起吃吗？", "en": "Can it be taken with DITROPAN XL, VESIcare or MYRBETRIQ?" }, "answer": { "zh": "网页不能只凭商品名决定。它们成分、作用和风险边界不同；重复抗胆碱作用、尿潴留、便秘、头晕、嗜睡、认知和跌倒风险需要结合完整药单、诊断和个人情况由专业人员核对。", "en": "The site cannot decide from brand names alone. Ingredients, actions and risk boundaries differ; duplicate anticholinergic effects, urinary retention, constipation, dizziness, drowsiness, cognition and fall risk require professional review of the complete medicine list, diagnosis and individual context." } }, { "question": { "zh": "页面有包装图，是否表示美国现在还能买到？", "en": "Does a package image mean it is currently available in the United States?" }, "answer": { "zh": "不表示。图片对应两个有日期的 30 粒瓶装 NDC，DailyMed 记录的营销终止日为 2026-07-31；Orange Book 的 RLD/RS 身份、标签档案、实时库存和购买资格是不同证据层级。", "en": "No. The images correspond to two dated 30-capsule NDCs whose DailyMed marketing end date is 31 Jul 2026. Orange Book RLD/RS identity, a label archive, real-time stock and purchasing eligibility are different evidence layers." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/detrol-la/", "en": "https://origindrug.com/en/drugs/detrol-la/" }, "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." ] }