{ "id": "ditropan-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DITROPAN XL", "generic": "盐酸奥昔布宁缓释片", "aliases": [ "Ditropan XL", "oxybutynin chloride extended release", "oxybutynin ER", "oxybutynin XL", "盐酸奥昔布宁缓释片", "奥昔布宁缓释片", "oxybutynin", "oxybutynin chloride", "oxybutynin extended release", "盐酸奥昔布宁", "NDA 020897", "5 XL", "10 XL", "15 XL" ], "marketBrandNames": [ { "name": "DITROPAN XL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 020897 历史 RLD；5、10、15 mg 当前均列为 Discontinued。", "en": "Historical RLD under NDA 020897; 5, 10 and 15 mg are currently listed as Discontinued." }, "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "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 NDA 020897：DITROPAN XL 5 mg、10 mg 与 15 mg 缓释片均为历史 RLD，当前 Orange Book/Drugs@FDA 状态为 Discontinued；2021 标签覆盖 5 mg、10 mg，15 mg 外观来自 2015 有日期标签。可阅读的说明书和 NDA 档案不等于当前有货、可购买、可自行换药或适合个人。", "dosageFormClass": "盐酸奥昔布宁渗透泵缓释口服片：每片 5、10 或 15 mg；必须整片吞服，不能咀嚼、分开或压碎；不是普通即释片、糖浆或贴剂", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（5 mg、10 mg）；1999（15 mg）", "archiveSponsorText": "ALZA Corporation／Janssen Pharmaceuticals, Inc.（FDA 历史品牌资料所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DITROPAN immediate release", "oxybutynin immediate-release tablet", "oxybutynin syrup", "oxybutynin transdermal system", "奥昔布宁普通片", "奥昔布宁口服液", "奥昔布宁贴剂", "other oxybutynin brands", "其他厂牌奥昔布宁" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ditropan-xl-oxybutynin-chloride-5mg-tablet-nda-020897-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA 2021 有日期美国标签", "en": "Dated 2021 U.S. FDA label" }, "dosageForm": { "zh": "DITROPAN XL 盐酸奥昔布宁缓释口服片", "en": "DITROPAN XL oxybutynin chloride extended-release oral tablet" }, "route": { "zh": "口服（完整渗透泵缓释片身份字段）", "en": "oral (intact osmotic extended-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020897 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸奥昔布宁 5 mg；美国原品牌 RLD 已停止销售", "en": "Oxybutynin chloride 5 mg per tablet; U.S. originator RLD discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸奥昔布宁", "en": "oxybutynin chloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时刻、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "historical_product_record", "typeLabel": { "zh": "历史产品记录；准确零售包装数量未由本页推定", "en": "historical product record; exact retail pack count not inferred here" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个 FDA 历史产品身份（不是一片装）", "en": "FDA historical product identity (not a one-tablet pack)" } }, "physicalClues": { "color": { "zh": "淡黄色", "en": "pale yellow" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片；不得咀嚼、分开或压碎", "en": "round, biconvex, unscored extended-release tablet; do not chew, divide or crush" }, "imprint": "5 XL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ditropan-xl-oxybutynin-chloride-10mg-tablet-nda-020897-product-002", "marketCode": "US", "labelVersion": { "zh": "FDA 2021 有日期美国标签", "en": "Dated 2021 U.S. FDA label" }, "dosageForm": { "zh": "DITROPAN XL 盐酸奥昔布宁缓释口服片", "en": "DITROPAN XL oxybutynin chloride extended-release oral tablet" }, "route": { "zh": "口服（完整渗透泵缓释片身份字段）", "en": "oral (intact osmotic extended-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020897 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸奥昔布宁 10 mg；美国原品牌 RLD 已停止销售", "en": "Oxybutynin chloride 10 mg per tablet; U.S. originator RLD discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸奥昔布宁", "en": "oxybutynin chloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时刻、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "historical_product_record", "typeLabel": { "zh": "历史产品记录；准确零售包装数量未由本页推定", "en": "historical product record; exact retail pack count not inferred here" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个 FDA 历史产品身份（不是一片装）", "en": "FDA historical product identity (not a one-tablet pack)" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片；不得咀嚼、分开或压碎", "en": "round, biconvex, unscored extended-release tablet; do not chew, divide or crush" }, "imprint": "10 XL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ditropan-xl-oxybutynin-chloride-15mg-tablet-nda-020897-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA 2015 有日期美国标签", "en": "Dated 2015 U.S. FDA label" }, "dosageForm": { "zh": "DITROPAN XL 盐酸奥昔布宁缓释口服片", "en": "DITROPAN XL oxybutynin chloride extended-release oral tablet" }, "route": { "zh": "口服（完整渗透泵缓释片身份字段）", "en": "oral (intact osmotic extended-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020897 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸奥昔布宁 15 mg；美国原品牌 RLD 已停止销售", "en": "Oxybutynin chloride 15 mg per tablet; U.S. originator RLD discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸奥昔布宁", "en": "oxybutynin chloride" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时刻、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "historical_product_record", "typeLabel": { "zh": "历史产品记录；准确零售包装数量未由本页推定", "en": "historical product record; exact retail pack count not inferred here" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个 FDA 历史产品身份（不是一片装）", "en": "FDA historical product identity (not a one-tablet pack)" } }, "physicalClues": { "color": { "zh": "灰色", "en": "grey" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片；不得咀嚼、分开或压碎", "en": "round, biconvex, unscored extended-release tablet; do not chew, divide or crush" }, "imprint": "15 XL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d9e6084cbc856cc0", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片历史处方信息（2015；含 15 mg 外观记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验三个强度的颜色、形状、刻印和历史 RLD 身份；未把非原品牌或再包装图片冒充为原包装", "en": "Colour, shape, imprint and historical RLD identity are verified for three strengths; no generic or repackaged image is presented as the originator pack" }, "summary": { "zh": "2021 FDA 标签列出 5 mg 淡黄色“5 XL”和 10 mg 粉红色“10 XL”；2015 标签另列 15 mg 灰色“15 XL”。本次未取得与三个历史原品牌零售包装一一对应的官方展示面，因此只提供文字身份卡和可放大说明书，不使用零售图、药片网站图或仿制品图片替代。", "en": "The 2021 FDA label lists pale-yellow 5 mg ‘5 XL’ and pink 10 mg ‘10 XL’ tablets; the 2015 label also lists grey 15 mg ‘15 XL’. No official display panels matched one-to-one to all three historical originator retail packs were obtained, so the page provides text identity cards and enlarged labels without substituting retail, pill-database or generic-product images." }, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DITROPAN XL 说明书放大阅读：不能掰碎，空壳可能随大便排出", "en": "DITROPAN XL label reading: do not split or crush; the shell may pass in stool" }, "summary": { "zh": "FDA 标签要求用液体整片吞服，不得咀嚼、分开或压碎。药物装在不可吸收的渗透泵外壳中，释药后外壳可能随大便排出；看到像药片的空壳不能据此补吃。", "en": "The FDA label says to swallow the tablet whole with liquids and not chew, divide or crush it. Medicine is held in a nonabsorbable osmotic shell that may pass in stool after release; seeing something tablet-like does not justify taking an extra tablet." }, "checks": [ { "zh": "5、10、15 mg 是每片标签量，不是个人一次片数。两个 5 mg 在算术上等于 10 mg，也不能据此自行拼片、加减量、替换 10 mg 产品或照搬他人的处方。", "en": "5, 10 and 15 mg are labelled amounts per tablet, not an individual's tablet count. Although two 5 mg numbers add to 10 mg, that does not permit self-assembling tablets, changing an amount, replacing a 10 mg product or copying another person's prescription." }, { "zh": "片剂必须保持完整，不要掰、切、嚼、溶解或压碎。吞咽困难时应带准确药盒和处方询问药师或开方团队，而不是自行破坏缓释结构或换成糖浆、普通片、贴剂。", "en": "Keep the tablet intact; do not split, cut, chew, dissolve or crush it. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber instead of disrupting extended release or self-switching to syrup, immediate-release tablets or a patch." }, { "zh": "口干、便秘、尿不出、嗜睡、头晕、视物模糊、意识混乱或幻觉可能与抗胆碱作用有关。老人、认知功能下降者及同时使用安眠药、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, inability to urinate, drowsiness, dizziness, blurred vision, confusion or hallucinations may relate to anticholinergic effects. Older adults, people with cognitive impairment and those using sleeping, allergy, nausea, bladder or other anticholinergic medicines need priority review of the complete medicine list." }, { "zh": "面唇舌喉肿胀或呼吸困难需要立即急救；高温环境下少汗、体温升高、意识变化也可能是严重情况。严重便秘、腹胀、不能排便排气或尿潴留需要尽快医疗评估。", "en": "Swelling of the face, lips, tongue or throat or difficulty breathing needs emergency help. Reduced sweating, high temperature or mental-status change in heat can also be serious. Severe constipation, distension, inability to pass stool or gas, or urinary retention needs prompt medical assessment." }, { "zh": "尿潴留、胃潴留或严重胃肠动力下降、未控制的闭角型青光眼属于标签禁忌；重症肌无力、自主神经病变、反流性食管炎、肝肾功能问题及痴呆治疗用药也应主动告知专业人员。", "en": "Urinary retention, gastric retention or severe reduced gastrointestinal motility and uncontrolled narrow-angle glaucoma are labelled contraindications. Myasthenia gravis, autonomic neuropathy, reflux disease, liver or kidney problems and dementia medicines also need to be disclosed to the professional." } ], "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "DITROPAN XL 怎样起作用：阻断毒蕈碱受体与渗透泵缓释是两层不同概念", "en": "How DITROPAN XL works: muscarinic blockade and osmotic extended release are two different layers" }, "summary": { "zh": "奥昔布宁及其活性代谢物通过抗毒蕈碱作用降低膀胱平滑肌相关活动；OROS 外壳则利用渗透压控制药物释放。作用机制解释产品设计，不证明某个老人一定适合，也不能从症状、年龄或毫克数生成个人方案。", "en": "Oxybutynin and its active metabolite act through antimuscarinic effects related to bladder smooth muscle, while the OROS shell uses osmotic pressure to control release. Mechanism explains product design; it does not prove suitability for an older person or generate an individual plan from symptoms, age or milligrams." }, "checks": [ { "zh": "减少膀胱急迫感的机制同时可能影响口腔、肠道、眼睛、排尿、出汗和中枢神经系统，所以不能只看“膀胱药”而忽略全身不适和完整药单。", "en": "The same mechanism used for bladder urgency can also affect the mouth, bowel, eyes, urination, sweating and central nervous system, so a ‘bladder medicine’ label must not hide whole-body symptoms or the complete medicine list." }, { "zh": "缓释片、普通奥昔布宁片、糖浆和贴剂的释放与吸收路径不同；不要按相同毫克数自行叠加、轮换或互换，也不要与 VESIcare、MYRBETRIQ 等其他膀胱药自行同服。", "en": "Extended-release tablets, immediate-release oxybutynin, syrup and patches have different release and absorption paths. Do not self-combine, alternate or exchange them by matching milligrams, or add another bladder medicine such as VESIcare or MYRBETRIQ without review." }, { "zh": "全基因筛查不是网页为这类选择设定的通用前提。实际核对更需要准确诊断、症状目标、认知与跌倒风险、排尿与肠道情况、青光眼史、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 history, liver and kidney function, and all medicines." } ], "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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": "DITROPAN XL", "generic": "盐酸奥昔布宁缓释片", "dosageFormClass": "盐酸奥昔布宁渗透泵缓释口服片：每片 5、10 或 15 mg；必须整片吞服，不能咀嚼、分开或压碎；不是普通即释片、糖浆或贴剂" }, "labelSource": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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" }, "productRoutes": [ { "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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." } }, { "source": { "id": "src_d9e6084cbc856cc0", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片历史处方信息（2015；含 15 mg 外观记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_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." } }, { "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "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." } } ], "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": "2026-08-29", "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": "DITROPAN XL 是盐酸奥昔布宁渗透泵缓释片的美国历史原品牌档案。最需要看懂的三点是：5、10、15 mg 都是每片强度，不是一次吃几片；片剂必须整片吞服，不能掰、切、嚼或压碎；空壳可能随大便排出，不应因此补吃。老人出现口干、便秘、尿潴留、嗜睡、视物模糊、过热或意识变化时，还要核对完整药单和抗胆碱负担。本页不提供个人剂量、停药或换药方案。", "history": "FDA 原始资料记录 NDA 020897 于 1998-12-16 批准 5 mg 与 10 mg，并于 1999-06-22 批准 15 mg。产品采用 OROS 渗透泵系统，水分进入片芯后推动药物通过激光微孔缓慢释放。当前美国原品牌三个规格均列为停止销售；页面保留有日期标签和监管历史，不将其写成当前供应。", "sourceDocuments": [ { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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_d9e6084cbc856cc0", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片历史处方信息（2015；含 15 mg 外观记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "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_90bd13ae76e8ae0a", "label": "FDA：DITROPAN XL NDA 020897 原始批准与医学审评资料（1998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897_appltr_medr.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 020897（DITROPAN XL / oxybutynin chloride extended-release tablets；三个历史 RLD 均已停止销售）", "approvalTimeline": [ { "date": "1998-12-16", "title": { "zh": "FDA 批准 5 mg 与 10 mg DITROPAN XL", "en": "FDA approved DITROPAN XL 5 mg and 10 mg" }, "detail": { "zh": "FDA 原始批准资料把两个渗透泵缓释规格与 NDA 020897、ALZA 和膀胱过度活动症状适应症相连。", "en": "The FDA original approval material links the two osmotic extended-release strengths to NDA 020897, ALZA and overactive-bladder symptoms." }, "source": { "id": "src_90bd13ae76e8ae0a", "label": "FDA：DITROPAN XL NDA 020897 原始批准与医学审评资料（1998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897_appltr_medr.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": "1999-06-22", "title": { "zh": "FDA 批准 15 mg 产品", "en": "FDA approved the 15 mg product" }, "detail": { "zh": "当前 Orange Book 档案保留 Product 003、15 mg、RLD 与该批准日期；现状态为 Discontinued。", "en": "The current Orange Book archive retains Product 003, 15 mg, RLD identity and this approval date; status is now Discontinued." }, "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "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" } }, { "date": "2021", "title": { "zh": "FDA 最近核验的有日期标签节点", "en": "Most recent dated FDA label node reviewed" }, "detail": { "zh": "2021 S-038 标签列 5 mg 与 10 mg，并强化整片吞服、抗胆碱中枢作用、血管性水肿和热衰竭等阅读边界；它不证明产品仍在销售。", "en": "The 2021 S-038 label lists 5 mg and 10 mg and supports whole-tablet, anticholinergic CNS, angioedema and heat-prostration reading boundaries; it does not prove continued marketing." }, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.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" } }, { "date": "2026-08-29", "title": { "zh": "复核美国当前产品状态", "en": "Current U.S. product status reviewed" }, "detail": { "zh": "NDA 020897 的 5、10、15 mg 三个 RLD 产品均列为 Discontinued。该日是本站复核日，不是停止销售决定日期。", "en": "All three 5, 10 and 15 mg RLD products under NDA 020897 are listed as Discontinued. This is the site's review date, not the discontinuation decision date." }, "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "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": "历史 RLD 档案；5、10、15 mg 均已停止销售", "en": "Historical RLD archive; 5, 10 and 15 mg are discontinued" }, "detail": { "zh": "页面提供三种文字身份卡、有日期说明书和历史审评入口，不提供库存、购买、真伪、可替代性或个人适用性结论。", "en": "The page provides three text identity cards, dated labels and historical review routes; it does not establish stock, purchase, authenticity, interchangeability 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": "不从美国历史品牌、NDA、RLD、通用名、毫克数或外观推定当地商品名、批准、包装、供应或可替代性。", "en": "No local brand, approval, pack, supply or interchangeability is inferred from the historical U.S. brand, NDA, RLD identity, generic name, milligrams or appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "大便里看到像药片的东西，是不是药没吸收？", "en": "Does something tablet-like in stool mean the medicine was not absorbed?" }, "answer": { "zh": "不一定。FDA 标签说明不可吸收的释药外壳可能随大便排出。不要因此补吃一片；若症状控制异常、持续担忧或伴有严重胃肠症状，请联系专业人员。", "en": "Not necessarily. The FDA label says the nonabsorbable release shell may pass in stool. Do not take an extra tablet because of this; contact a professional for unusual symptom control, persistent concern or serious gastrointestinal symptoms." } }, { "question": { "zh": "10 mg 可以掰一半当 5 mg 吗？", "en": "Can a 10 mg tablet be split to make 5 mg?" }, "answer": { "zh": "不能自行这样做。DITROPAN XL 是无刻痕渗透泵缓释片，FDA 标签要求整片吞服、不得咀嚼、分开或压碎。需要调整时应核对准确处方和可用产品。", "en": "Do not do this yourself. DITROPAN XL is an unscored osmotic extended-release tablet, and the FDA label requires swallowing whole without chewing, dividing or crushing. Any adjustment requires review of the exact prescription and available product." } }, { "question": { "zh": "和 VESIcare、MYRBETRIQ 或奥昔布宁普通片能一起吃吗？", "en": "Can it be taken with VESIcare, MYRBETRIQ or immediate-release oxybutynin?" }, "answer": { "zh": "网页不能仅凭药名决定。它们成分、作用和不良反应边界不同；重复抗胆碱作用、尿潴留、便秘、嗜睡、认知和跌倒风险都需要结合完整药单、诊断和个体情况由专业人员核对。", "en": "The site cannot decide from names alone. Ingredients, actions and adverse-effect boundaries differ; duplicate anticholinergic effects, urinary retention, constipation, drowsiness, cognition and fall risk require professional review of the complete medicine list, diagnosis and individual context." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ditropan-xl/", "en": "https://origindrug.com/en/drugs/ditropan-xl/" }, "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." ] }