{ "id": "suprax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "SUPRAX", "generic": "头孢克肟", "aliases": [ "Suprax", "cefixime", "cefixime trihydrate", "头孢克肟", "头孢克肟胶囊", "头孢克肟混悬液", "NDA 202091", "NDA 203195" ], "marketBrandNames": [ { "name": "SUPRAX", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "FDA Orange Book 当前列出 NDA 203195 的 400 mg 胶囊及 NDA 202091 的 500 mg/5 mL 混悬液；DailyMed 标签同时含其他 ANDA 剂型，页面只把准确 NDA 产品作为本档案核心。", "en": "The current FDA Orange Book lists the 400 mg capsule under NDA 203195 and 500 mg/5 mL suspension under NDA 202091. The DailyMed label also contains other ANDA forms; this dossier keeps the exact NDA products at its core." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "SUPRAX", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada DPD 分别列出 Marketed 的 100 mg/5 mL、DIN 00868965 与 400 mg、DIN 00868981；加拿大产品不得用美国 NDC、浓度或包装替代。", "en": "Health Canada's DPD separately lists marketed 100 mg/5 mL DIN 00868965 and 400 mg DIN 00868981 products. U.S. NDCs, concentrations and packs must not substitute for the Canadian identities." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 SUPRAX 100 mg/5 mL／DIN 00868965", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 当前 Orange Book：SUPRAX 400 mg 口服胶囊 NDA 203195 与 500 mg/5 mL 口服混悬液 NDA 202091 为 RX、RLD 与 RS；加拿大 DPD 另有 Marketed 的 100 mg/5 mL（DIN 00868965）和 400 mg（DIN 00868981）SUPRAX。市场与剂型不得合并。", "dosageFormClass": "美国当前两个 NDA 产品：400 mg/粒口服胶囊；按标签复溶后 500 mg/5 mL 口服混悬液。DailyMed 同一标签还列出其他 ANDA 片剂、咀嚼片和混悬液浓度，它们不并入这四个 NDA 包装身份。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989", "archiveSponsorText": "Lupin Limited（FDA Orange Book 当前 NDA 202091 / 203195 申请方）；加拿大记录另列 ODAN Laboratories Ltd." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "SUPRAX", "Suprax cefixime", "头孢克肟", "头孢克肟胶囊", "头孢克肟 500 mg/5 mL" ], "excludedProductCues": [ "cefixime 100 mg/5 mL", "cefixime 200 mg/5 mL", "cefixime 400 mg tablet", "cefixime chewable tablet", "头孢克肟片", "头孢克肟咀嚼片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-suprax-cefixime-400mg-50-capsule-bottle-ndc-2743720808", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 400 mg 口服胶囊", "en": "SUPRAX cefixime 400 mg oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-208-08", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含头孢克肟 400 mg；50 粒瓶装", "en": "Cefixime 400 mg per capsule; 50-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 400, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "粒/包装", "en": "capsules per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "粒/包装", "en": "capsules per pack" } }, "physicalClues": { "color": { "zh": "粉红色不透明帽与粉红色不透明体", "en": "pink opaque cap and pink opaque body" }, "shape": { "zh": "00EL 号胶囊；无刻痕", "en": "size 00EL capsule; unscored" }, "imprint": "LU / U43", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-suprax-cefixime-400mg-10-unit-dose-capsule-blister-ndc-2743720811", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 400 mg 口服胶囊", "en": "SUPRAX cefixime 400 mg oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-208-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含头孢克肟 400 mg；10 粒单位剂量泡罩包装", "en": "Cefixime 400 mg per capsule; 10-capsule unit-dose blister pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 400, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "单位剂量泡罩包装", "en": "unit-dose blister pack" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "粒/包装", "en": "capsules per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "粒/包装", "en": "capsules per pack" } }, "physicalClues": { "color": { "zh": "粉红色不透明帽与粉红色不透明体", "en": "pink opaque cap and pink opaque body" }, "shape": { "zh": "00EL 号胶囊；无刻痕", "en": "size 00EL capsule; unscored" }, "imprint": "LU / U43", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-suprax-cefixime-500mg-per-5ml-10ml-bottle-ndc-2743720702", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 500 mg/5 mL 口服混悬液用粉末", "en": "SUPRAX cefixime 500 mg/5 mL powder for oral suspension" }, "route": { "zh": "口服；复溶后混悬液（准确浓度产品身份字段）", "en": "oral; suspension after reconstitution (exact concentration identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-207-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "按标签复溶后每 5 mL 含头孢克肟 500 mg；10 mL 瓶装", "en": "Cefixime 500 mg per 5 mL after reconstitution as labelled; 10 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "按标签复溶后每 5 mL 的浓度；不是个人毫升数、频率、疗程或调配指令", "en": "concentration per 5 mL after labelled reconstitution; not an individual's millilitres, frequency, course or mixing instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "待复溶粉末瓶", "en": "powder-for-reconstitution bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "mL/瓶（复溶后标示包装体积）", "en": "mL per bottle (labelled reconstituted pack volume)" } }, "physicalClues": { "color": { "zh": "类白色至乳白色粉末；复溶后为类白色至淡黄色混悬液", "en": "off-white to cream powder; off-white to pale-yellow suspension after reconstitution" }, "shape": { "zh": "草莓味口服混悬液用粉末", "en": "strawberry-flavoured powder for oral suspension" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-suprax-cefixime-500mg-per-5ml-20ml-bottle-ndc-2743720703", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 500 mg/5 mL 口服混悬液用粉末", "en": "SUPRAX cefixime 500 mg/5 mL powder for oral suspension" }, "route": { "zh": "口服；复溶后混悬液（准确浓度产品身份字段）", "en": "oral; suspension after reconstitution (exact concentration identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-207-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "按标签复溶后每 5 mL 含头孢克肟 500 mg；20 mL 瓶装", "en": "Cefixime 500 mg per 5 mL after reconstitution as labelled; 20 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "按标签复溶后每 5 mL 的浓度；不是个人毫升数、频率、疗程或调配指令", "en": "concentration per 5 mL after labelled reconstitution; not an individual's millilitres, frequency, course or mixing instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "待复溶粉末瓶", "en": "powder-for-reconstitution bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "mL/瓶（复溶后标示包装体积）", "en": "mL per bottle (labelled reconstituted pack volume)" } }, "physicalClues": { "color": { "zh": "类白色至乳白色粉末；复溶后为类白色至淡黄色混悬液", "en": "off-white to cream powder; off-white to pale-yellow suspension after reconstitution" }, "shape": { "zh": "草莓味口服混悬液用粉末", "en": "strawberry-flavoured powder for oral suspension" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=70934-079-01+-+Rev+B+09-19.jpg&setid=655a59ba-08e9-51d4-e053-2991aa0aef34&type=img", "alt": "SUPRAX cefixime 400 mg capsule official DailyMed unit-dose label, NDC 70934-079-01", "archiveMarket": "美国", "labelVersion": "Rev. B 09/19", "presentation": "SUPRAX／cefixime 400 mg 胶囊单位剂量标签；再包装 NDC 70934-079-01，标注原生产 NDC 27437-208-08", "notice": "这是 DailyMed 公开标签中的单位剂量再包装标签图，可核对 SUPRAX、cefixime、400 mg、每粒、NDC 70934-079-01 与原生产 NDC 27437-208-08。它不是 50 粒原瓶正面图，不用于鉴定真伪，也不证明当前库存、其他包装、其他市场身份或个人适用性。", "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SUPRAX 说明书放大阅读：先区分“每粒 400 mg”和“每 5 mL 500 mg”", "en": "SUPRAX label reading: first separate 400 mg per capsule from 500 mg per 5 mL" }, "summary": { "zh": "胶囊标示的是每粒含量，混悬液标示的是按标签复溶后的浓度。它们都属于产品身份，不是个人一次用量。先核对准确剂型、浓度、NDC、处方和量具，再由医生或药师确认个人方案。", "en": "The capsule states an amount per capsule; the suspension states a concentration after labelled reconstitution. Both are product-identity fields, not an individual's amount per use. Check the exact form, concentration, NDC, prescription and measuring device before a clinician or pharmacist confirms an individual plan." }, "checks": [ { "zh": "400 mg 是每粒胶囊中的标签标示量；500 mg/5 mL 是混悬液复溶后的浓度。不要把“总 mg 看起来一样”理解为胶囊和液体能自行换算、互换、拆分或补服。", "en": "400 mg is the labelled amount in each capsule; 500 mg/5 mL is the concentration after suspension reconstitution. A similar total milligram number does not make capsule and liquid self-convertible, interchangeable, divisible or suitable for making up a missed use." }, { "zh": "同一 DailyMed 标签还列出 100 mg/5 mL、200 mg/5 mL、500 mg/5 mL 三种混悬液浓度。任何以 mL 表示的医嘱都必须同时写清准确浓度；网页不会只凭“几毫升”或年龄体重补出个人处方。", "en": "The same DailyMed label lists 100 mg/5 mL, 200 mg/5 mL and 500 mg/5 mL suspension concentrations. Any order expressed in mL must also identify the exact concentration; the site will not derive a personal prescription from millilitres, age or weight." }, { "zh": "对头孢克肟、其他头孢菌素或青霉素有过敏史，应在使用前告诉开方团队。呼吸困难、面部或咽喉肿胀、晕厥、广泛皮疹或其他严重过敏表现需要立即使用当地急救服务。", "en": "Tell the prescriber about previous reactions to cefixime, other cephalosporins or penicillins. Breathing difficulty, facial or throat swelling, fainting, widespread rash or another severe allergic feature requires immediate local emergency care." }, { "zh": "严重、持续或带血腹泻，明显腹痛、发热、脱水或虚弱需要尽快医疗评估；标签说明相关问题可能在抗菌药结束后出现。不要自行用止泻药掩盖严重症状。", "en": "Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration or weakness needs prompt medical assessment. The label explains that the problem can appear after antibacterial treatment has ended. Do not self-use an antidiarrhoeal medicine to mask severe symptoms." }, { "zh": "老年人或肾功能受损者需要由专业人员核对肾功能和处方。服用卡马西平、华法林或其他抗凝药的人，应把完整药单交给医生或药师复核；不要从网页自行减量、隔天用或换浓度。", "en": "Older adults or people with impaired kidney function need professional review of kidney function and the prescription. People taking carbamazepine, warfarin or another anticoagulant should give the complete medicine list to a clinician or pharmacist; do not self-reduce, alternate days or change concentration from the website." }, { "zh": "混悬液必须按准确瓶装说明复溶，并使用适合的量具；家用汤匙、目测液面或把剩余药液倒进另一瓶都不能保证准确。配制、保存、摇匀和丢弃时间请以手中产品现行说明书及药师指示为准。", "en": "The suspension must be reconstituted according to the exact bottle instructions and measured with a suitable device. A household spoon, visual liquid level or transfer into another bottle cannot ensure accuracy. Follow the current label for the product in hand and pharmacist instructions for mixing, storage, shaking and discard timing." } ], "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "头孢克肟怎样起作用：抑制细菌细胞壁合成，不等于对所有感染都有效", "en": "How cefixime works: inhibiting bacterial cell-wall synthesis does not mean it treats every infection" }, "summary": { "zh": "FDA 审评资料将头孢克肟描述为口服头孢菌素抗菌药，通过抑制细菌细胞壁合成发挥抗菌作用。机制帮助理解药物类别，但不能仅凭发热、咳嗽、咽痛、尿路或其他症状判断是否为细菌感染、是否敏感或该用多久。", "en": "FDA review material describes cefixime as an oral cephalosporin antibacterial that acts by inhibiting bacterial cell-wall synthesis. The mechanism helps explain the class but cannot establish from fever, cough, sore throat, urinary or other symptoms whether an infection is bacterial, susceptible or how long treatment should last." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要使用剩药、借用他人药品、因症状相似自行开始，或在感觉好转后自行缩短处方疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, borrow another person's medicine, self-start because symptoms seem similar or shorten a prescribed course because you feel better." }, { "zh": "SUPRAX、KEFLEX、CEFTIN、阿莫西林、阿莫西林/克拉维酸、阿奇霉素和左氧氟沙星都可能出现在感染相关处方中，但不表示可以自行叠加、轮换或替代。", "en": "SUPRAX, KEFLEX, CEFTIN, amoxicillin, amoxicillin/clavulanate, azithromycin and levofloxacin may all appear in infection-related prescribing, but that does not make them self-combinable, alternatable or substitutable." }, { "zh": "感染部位、培养或药敏结果、过敏史、肾功能、年龄和完整药单都会影响专业判断；网页只帮助读懂准确说明书和提出问题，不替个人选择抗菌药。", "en": "Infection site, culture or susceptibility results, allergy history, kidney function, age and the complete medicine list can affect professional judgement. The site helps read the exact label and frame questions; it does not choose an antibacterial for an individual." } ], "source": { "id": "src_032efcd9844a80ad", "label": "FDA：SUPRAX／cefixime 500 mg/5 mL NDA 202091 临床审评（机制与监管背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "SUPRAX", "generic": "头孢克肟", "dosageFormClass": "美国当前两个 NDA 产品：400 mg/粒口服胶囊；按标签复溶后 500 mg/5 mL 口服混悬液。DailyMed 同一标签还列出其他 ANDA 片剂、咀嚼片和混悬液浓度，它们不并入这四个 NDA 包装身份。" }, "labelSource": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "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": "2026-08-31", "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_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "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": "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": "2026-08-31", "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": "SUPRAX 是头孢克肟品牌档案。美国当前 NDA 产品包括 400 mg 口服胶囊和复溶后 500 mg/5 mL 口服混悬液；两者的“每粒 mg”和“每 5 mL 浓度”不是同一种单位。本页分开呈现准确包装、说明书、作用机理、过敏和严重腹泻警示、肾功能与联用药核对，不把包装数字换算成个人该吃几粒或几毫升。", "history": "美国旧 SUPRAX 200/400 mg 片剂 NDA 050621 和 100 mg/5 mL 混悬液 NDA 050622 于 1989-04-28 获批，当前 Orange Book 标为 DISCN，并注明 FDA 判定并非因安全性或有效性撤回。当前 RX 产品为 2012 年获批的 400 mg 胶囊 NDA 203195 和 2013 年获批的 500 mg/5 mL 混悬液 NDA 202091。加拿大的同名产品由当地 DPD 单独记录。", "sourceDocuments": [ { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 SUPRAX 100 mg/5 mL／DIN 00868965", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 SUPRAX 400 mg／DIN 00868981", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "FDA NDA 202091（500 mg/5 mL suspension）／NDA 203195（400 mg capsule）", "approvalTimeline": [ { "date": "1989-04-28", "title": { "zh": "旧 SUPRAX 片剂与混悬液获 FDA 批准", "en": "Earlier SUPRAX tablet and suspension NDAs approved" }, "detail": { "zh": "NDA 050621 的 200/400 mg 片剂和 NDA 050622 的 100 mg/5 mL 混悬液后来停止上市；Orange Book 注明 FDA 判定并非因安全性或有效性撤回。历史状态不代表当前供应。", "en": "The 200/400 mg tablets under NDA 050621 and 100 mg/5 mL suspension under NDA 050622 were later discontinued. Orange Book notes FDA determined they were not withdrawn for safety or effectiveness. Historical status does not establish current supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2012-06-01", "title": { "zh": "SUPRAX 400 mg 胶囊 NDA 203195 获批", "en": "SUPRAX 400 mg capsule NDA 203195 approved" }, "detail": { "zh": "FDA 批准信把 SUPRAX 400 mg 胶囊与 NDA 203195 相连。当前 Orange Book 将其列为 RX、参比制剂和参比标准。", "en": "The FDA approval letter links SUPRAX 400 mg capsules to NDA 203195. The current Orange Book lists it as prescription, reference listed drug and reference standard." }, "source": { "id": "src_473f66126918d09e", "label": "FDA：SUPRAX 400 mg 胶囊 NDA 203195 批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2013-02-20", "title": { "zh": "SUPRAX 500 mg/5 mL 混悬液 NDA 202091 获批", "en": "SUPRAX 500 mg/5 mL suspension NDA 202091 approved" }, "detail": { "zh": "FDA 审评资料将 500 mg/5 mL 口服混悬液与 NDA 202091 相连；当前 Orange Book 将其列为 RX、参比制剂和参比标准。", "en": "FDA review material links the 500 mg/5 mL oral suspension to NDA 202091. The current Orange Book lists it as prescription, reference listed drug and reference standard." }, "source": { "id": "src_032efcd9844a80ad", "label": "FDA：SUPRAX 500 mg/5 mL 混悬液 NDA 202091 临床审评", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两个当前 RX NDA 产品已核验", "en": "Two current prescription NDA products verified" }, "detail": { "zh": "当前 Orange Book 列出 400 mg 胶囊 NDA 203195 与 500 mg/5 mL 混悬液 NDA 202091。本页只记录准确监管与包装身份，不证明任何地点库存、可购买或个人适用。", "en": "The current Orange Book lists the 400 mg capsule under NDA 203195 and 500 mg/5 mL suspension under NDA 202091. The dossier records exact regulatory and package identity and does not establish local stock, purchase availability or individual suitability." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "两个 Marketed SUPRAX 产品记录已核验", "en": "Two marketed SUPRAX product records verified" }, "detail": { "zh": "Health Canada DPD 分别列出 DIN 00868965 的 100 mg/5 mL 和 DIN 00868981 的 400 mg SUPRAX；不从加拿大记录推定美国 NDC、剂型细节或其他市场身份。", "en": "Health Canada's DPD separately lists 100 mg/5 mL DIN 00868965 and 400 mg DIN 00868981 SUPRAX. Canadian records do not establish U.S. NDCs, form details or another market's identity." } }, { "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 record not established" }, "detail": { "zh": "不从 SUPRAX 商品名、cefixime 通用名或包装颜色推定当地批准、商品名、剂型、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local approval, trade name, form, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the SUPRAX name, cefixime generic name or package colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "400 mg 胶囊与 500 mg/5 mL 混悬液是不是可以直接换算？", "en": "Can the 400 mg capsule and 500 mg/5 mL suspension be directly converted?" }, "answer": { "zh": "不能自行换算或替换。一个是每粒含量，一个是复溶后浓度；剂型、吸收、准确处方、量具、肾功能和感染情况都需要专业人员核对。网页不会把浓度算成个人毫升数。", "en": "Do not self-convert or substitute them. One is an amount per capsule and the other a concentration after reconstitution. Form, absorption, the exact prescription, measuring device, kidney function and infection all need professional review. The site will not turn concentration into an individual's millilitres." } }, { "question": { "zh": "胶囊可以打开倒一半，或者混悬液少摇几下吗？", "en": "Can the capsule be opened and halved, or the suspension shaken less?" }, "answer": { "zh": "不要自行这样做。页面核验的是完整胶囊和按准确标签复溶、摇匀、量取的混悬液。目测分半或未充分混匀都不能保证得到准确产品单位；改变前请让药师核对手中包装和处方。", "en": "Do not do this yourself. The dossier verifies an intact capsule and suspension reconstituted, shaken and measured according to the exact label. Visual halving or inadequate mixing cannot ensure an accurate product unit; ask a pharmacist to check the pack and prescription before changing anything." } }, { "question": { "zh": "以前感染剩下的 SUPRAX 能留到下次吃吗？", "en": "Can leftover SUPRAX from an earlier infection be saved for next time?" }, "answer": { "zh": "不要自行留用或复用。相似症状不等于同一病原、感染部位或敏感性；剩余药品的保存、复溶后期限、浓度和完整疗程也可能不适用。请让医生或药师重新评估。", "en": "Do not self-save or reuse it. Similar symptoms do not establish the same organism, infection site or susceptibility, and storage, post-reconstitution life, concentration and a complete course may no longer fit. Ask a clinician or pharmacist to reassess." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/suprax/", "en": "https://origindrug.com/en/drugs/suprax/" }, "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." ] }