{ "id": "nitrostat", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "NITROSTAT", "generic": "硝酸甘油舌下片", "aliases": [ "Nitrostat", "nitroglycerin sublingual tablets", "硝酸甘油舌下片", "硝酸甘油片", "nitroglycerin", "nitroglycerin sublingual", "glyceryl trinitrate", "硝酸甘油", "NDA 021134", "58151-309-01", "58151-310-01", "58151-311-01", "NITROSTAT 0.3 mg", "NITROSTAT 0.4 mg", "NITROSTAT 0.6 mg" ], "marketBrandNames": [ { "name": "NITROSTAT", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021134；0.3/0.4/0.6 mg 均为处方 RLD，0.6 mg 同时为 RS；三个现行 100 片包装面板已分开记录。", "en": "NDA 021134; 0.3/0.4/0.6 mg are prescription RLD products and 0.6 mg is also the RS; three current 100-tablet package panels are recorded separately." }, "source": { "id": "src_7f100d738fb4648f", "label": "FDA Drugs@FDA：NITROSTAT NDA 021134 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021134", "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": "心血管", "sourceArchiveMarket": "美国：DailyMed 的 Viatris NDA 品牌标签列出 NITROSTAT 0.3、0.4、0.6 mg 舌下片及三个准确 100 片原装玻璃瓶/纸盒面板。FDA Orange Book 将三个规格列为处方 RLD，并将 0.6 mg 列为 RS。标签与 RLD 记录不证明实时库存、个人适用性、个人使用次数，也不证明与贴片、喷雾、软膏、静脉制剂或其他硝酸酯可互换。", "dosageFormClass": "硝酸甘油舌下片：每片 0.3、0.4 或 0.6 mg；放在舌下或颊囊让其溶解，不可像常规片剂那样直接咽下；应保留在原装玻璃瓶并每次用后立即拧紧", "dosageFormClassCode": "other", "route": "舌下或颊囊含化（高风险急症产品身份字段；不是胃肠道给药）", "routeCode": "other", "historicalApprovalEntry": "1981（当前标签所列美国初始批准）／2000-05-01（NDA 021134 重新配方批准）", "archiveSponsorText": "Viatris Specialty LLC（FDA Orange Book 当前申请主体；DailyMed 品牌标签分销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "nitroglycerin extended-release capsules", "nitroglycerin transdermal patch", "nitroglycerin ointment", "nitroglycerin lingual spray", "nitroglycerin intravenous injection", "isosorbide mononitrate", "isosorbide dinitrate" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-nitrostat-nitroglycerin-sublingual-0-3mg-100-tablet-bottle-ndc-5815130901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Viatris NDA 品牌标签（2023-02-15 更新；包装面板 2024 发布）", "en": "U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)" }, "dosageForm": { "zh": "NITROSTAT 硝酸甘油舌下片", "en": "NITROSTAT nitroglycerin sublingual tablet" }, "route": { "zh": "舌下或颊囊含化（不是普通吞服片）", "en": "sublingual or buccal dissolution (not a conventional swallowed tablet)" }, "routeCodes": [ "sublingual", "buccal" ], "productCode": "NDC 58151-309-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸甘油 0.3 mg；100 片原装玻璃瓶/纸盒", "en": "Nitroglycerin 0.3 mg per tablet; original 100-tablet glass bottle/carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸甘油", "en": "nitroglycerin" }, "value": 0.3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频率、急救次数或疗程", "en": "label strength per tablet; not an individual's tablet count, frequency, emergency-use count or course" } } ], "concentration": null, "container": { "typeCode": "original_glass_bottle_carton", "typeLabel": { "zh": "100 片原装玻璃瓶及外盒", "en": "original 100-tablet glass bottle and carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色；纸盒紫色强度条", "en": "white; purple strength band on carton" }, "shape": { "zh": "白色、圆形、平面舌下片", "en": "white, round, flat-faced sublingual tablet" }, "imprint": "N / 3", "scoreStatus": "not_a_splitting_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-nitrostat-nitroglycerin-sublingual-0-4mg-100-tablet-bottle-ndc-5815131001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Viatris NDA 品牌标签（2023-02-15 更新；包装面板 2024 发布）", "en": "U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)" }, "dosageForm": { "zh": "NITROSTAT 硝酸甘油舌下片", "en": "NITROSTAT nitroglycerin sublingual tablet" }, "route": { "zh": "舌下或颊囊含化（不是普通吞服片）", "en": "sublingual or buccal dissolution (not a conventional swallowed tablet)" }, "routeCodes": [ "sublingual", "buccal" ], "productCode": "NDC 58151-310-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸甘油 0.4 mg；100 片原装玻璃瓶/纸盒", "en": "Nitroglycerin 0.4 mg per tablet; original 100-tablet glass bottle/carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸甘油", "en": "nitroglycerin" }, "value": 0.4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频率、急救次数或疗程", "en": "label strength per tablet; not an individual's tablet count, frequency, emergency-use count or course" } } ], "concentration": null, "container": { "typeCode": "original_glass_bottle_carton", "typeLabel": { "zh": "100 片原装玻璃瓶及外盒", "en": "original 100-tablet glass bottle and carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色；纸盒青绿色强度条", "en": "white; teal strength band on carton" }, "shape": { "zh": "白色、圆形、平面舌下片", "en": "white, round, flat-faced sublingual tablet" }, "imprint": "N / 4", "scoreStatus": "not_a_splitting_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-nitrostat-nitroglycerin-sublingual-0-6mg-100-tablet-bottle-ndc-5815131101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Viatris NDA 品牌标签（2023-02-15 更新；包装面板 2024 发布）", "en": "U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)" }, "dosageForm": { "zh": "NITROSTAT 硝酸甘油舌下片", "en": "NITROSTAT nitroglycerin sublingual tablet" }, "route": { "zh": "舌下或颊囊含化（不是普通吞服片）", "en": "sublingual or buccal dissolution (not a conventional swallowed tablet)" }, "routeCodes": [ "sublingual", "buccal" ], "productCode": "NDC 58151-311-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸甘油 0.6 mg；100 片原装玻璃瓶/纸盒", "en": "Nitroglycerin 0.6 mg per tablet; original 100-tablet glass bottle/carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸甘油", "en": "nitroglycerin" }, "value": 0.6, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频率、急救次数或疗程", "en": "label strength per tablet; not an individual's tablet count, frequency, emergency-use count or course" } } ], "concentration": null, "container": { "typeCode": "original_glass_bottle_carton", "typeLabel": { "zh": "100 片原装玻璃瓶及外盒", "en": "original 100-tablet glass bottle and carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色；纸盒红色强度条", "en": "white; red strength band on carton" }, "shape": { "zh": "白色、圆形、平面舌下片", "en": "white, round, flat-faced sublingual tablet" }, "imprint": "N / 6", "scoreStatus": "not_a_splitting_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-nitrostat-nitroglycerin-sublingual-0-4mg-100-tablet-bottle-ndc-5815131001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "alt": "NITROSTAT 0.4 mg、100 片、NDC 58151-310-01 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed Viatris 品牌标签；2023-02 更新，包装面板 2024 发布", "presentation": "NITROSTAT 硝酸甘油舌下片，每片 0.4 mg，100 片原装玻璃瓶/纸盒，NDC 58151-310-01。", "notice": "此图只对应所引美国标签中的 0.4 mg、100 片原装玻璃瓶/纸盒；不代表 0.3/0.6 mg、25 片瓶、贴片、喷雾、软膏、静脉制剂、其他市场或实时库存。它不用于鉴定真伪，也不生成个人片数或急救方案。", "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NITROSTAT 说明书放大阅读：这是一款舌下片，不是普通吞服片", "en": "NITROSTAT label reading: this is a sublingual tablet, not a conventional swallowed tablet" }, "summary": { "zh": "0.3、0.4 和 0.6 mg 都是每片强度。标签要求将片剂置于舌下或颊囊让其溶解，不得压碎、咀嚼或吞下；三种规格还必须保留在原装玻璃瓶内并每次使用后立即拧紧，避免效价降低。网页只帮助读懂准确产品，不替任何人制定胸痛应急次数。", "en": "The 0.3, 0.4 and 0.6 mg figures are strengths per tablet. The label says to place a tablet under the tongue or in the buccal pouch and allow it to dissolve; do not crush, chew or swallow it. All three strengths must remain in the original glass container and be tightly capped immediately after each use to prevent loss of potency. This page identifies the product and does not create anyone's chest-pain action count." }, "checks": [ { "zh": "先看给药途径：NITROSTAT 是舌下/颊囊含化片。吞下、压碎或咀嚼会偏离标签；也不能因为药片很小就把 0.3、0.4、0.6 mg 相加或自行决定片数。", "en": "Check the route first: NITROSTAT dissolves under the tongue or in the buccal pouch. Swallowing, crushing or chewing departs from the label. A small tablet does not permit adding 0.3, 0.4 and 0.6 mg figures or choosing a tablet count yourself." }, { "zh": "新发、与平时不同、剧烈或持续胸痛可能是急症。应立即按个人既定应急计划和当地急救系统求助；不要等待网页、网上咨询或自行更换规格来判断。", "en": "New, different, severe or persistent chest pain may be an emergency. Follow the established emergency plan and contact local emergency services immediately; do not wait for a website, online advice or a self-chosen strength change." }, { "zh": "标签将 PDE-5 抑制剂（如西地那非、他达拉非、伐地那非、阿伐那非）和可溶性鸟苷酸环化酶刺激剂列为禁忌联用，因为可能造成严重低血压。即使药物不是同一天服用，也应让医生或药师按具体产品与时间核对，不能靠网页自行估算间隔。", "en": "The label contraindicates PDE-5 inhibitors such as sildenafil, tadalafil, vardenafil and avanafil, and soluble guanylate cyclase stimulators, because severe hypotension may occur. Even when products were not taken on the same day, a clinician or pharmacist must review the exact product and timing; this site does not calculate a safe interval." }, { "zh": "老人、低血压、脱水或正在使用降压药、利尿药、酒精及其他血管扩张药的人，头晕、乏力、晕厥和跌倒风险尤其需要核对。出现晕厥、意识改变或严重虚弱应及时求助。", "en": "Older adults and people with low blood pressure, dehydration, antihypertensives, diuretics, alcohol or other vasodilators need particular review for dizziness, weakness, syncope and falls. Fainting, altered awareness or severe weakness requires prompt help." }, { "zh": "口腔没有灼热或刺麻感并不能证明药物没有释放；有头痛也不能证明产品真假或自行追加。判断应依据准确包装、效期、原瓶储存、处方和专业评估。", "en": "No burning or tingling in the mouth does not prove failure of release, and a headache does not prove authenticity or justify self-adding a tablet. Use the exact pack, expiry, original-container storage, prescription and professional assessment." }, { "zh": "每次使用后立即拧紧原装玻璃瓶；不要转入药盒、塑料袋或与其他药混装。外出携带、过期或瓶盖未紧时，向药师核对更换与储存，不要凭外观或刺麻感判断效价。", "en": "Tightly recap the original glass bottle immediately after each use. Do not transfer tablets to a pill organiser, plastic bag or a mixed container. Ask a pharmacist about travel storage, expiry or a bottle left open; appearance or tingling cannot establish potency." } ], "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硝酸甘油怎样起作用：释放一氧化氮相关信号，使血管平滑肌松弛", "en": "How nitroglycerin works: nitric-oxide-related signalling relaxes vascular smooth muscle" }, "summary": { "zh": "硝酸甘油在体内形成一氧化氮相关信号，激活鸟苷酸环化酶并增加环磷酸鸟苷，使血管平滑肌松弛。静脉扩张可减少回心血量和心脏负荷，动脉扩张也可降低阻力。这个机理解释了为什么会出现头痛、头晕和低血压，也解释了为何不能与增强同一通路的 PDE-5 抑制剂或 sGC 刺激剂同用；它不能用来推算个人片数。", "en": "Nitroglycerin generates nitric-oxide-related signalling, activates guanylate cyclase and increases cyclic GMP, relaxing vascular smooth muscle. Venodilation can reduce venous return and cardiac workload, while arterial dilation can reduce resistance. This explains headache, dizziness and hypotension and why PDE-5 inhibitors or sGC stimulators that amplify the pathway are contraindicated. It cannot be used to calculate an individual's tablet count." }, "checks": [ { "zh": "‘舌下’说明给药途径和起效设计，不表示药量更大；口服吞下、贴片、喷雾、软膏和静脉制剂具有不同产品边界，不能按共同成分或 mg 数自行替换。", "en": "‘Sublingual’ describes the route and onset design, not a larger amount. Swallowed, patch, spray, ointment and intravenous products have different product boundaries and cannot be self-substituted from a shared ingredient or milligrams." }, { "zh": "血压下降、脱水、酒精或其他扩血管/降压药可能叠加影响；网页不根据某个血压数字判断是否继续、追加或停用。", "en": "Blood-pressure reduction, dehydration, alcohol and other vasodilating or antihypertensive medicines may have additive effects. This site does not use one blood-pressure reading to decide continuation, addition or stopping." }, { "zh": "此类作用不需要常规全基因筛查来决定每个人是否使用；是否需要检查由临床情况、药物清单、血压和相关疾病决定。", "en": "This mechanism does not create a routine whole-genome-screening requirement for everyone. Testing decisions depend on the clinical situation, medicine list, blood pressure and relevant conditions." } ], "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "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": "NITROSTAT", "generic": "硝酸甘油舌下片", "dosageFormClass": "硝酸甘油舌下片：每片 0.3、0.4 或 0.6 mg；放在舌下或颊囊让其溶解，不可像常规片剂那样直接咽下；应保留在原装玻璃瓶并每次用后立即拧紧" }, "labelSource": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7f100d738fb4648f", "label": "FDA Drugs@FDA：NITROSTAT NDA 021134 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021134", "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": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "NITROSTAT 是硝酸甘油舌下片，不是像普通药片一样吞下。药盒上的 0.3、0.4 或 0.6 mg 指每片强度，不是一次该用几片。它必须和胸痛应急计划、完整药单以及西地那非、他达拉非、伐地那非、阿伐那非或可溶性鸟苷酸环化酶刺激剂等禁忌联用信息一起核对。新发、异常、剧烈或持续胸痛应立即按当地急救路径求助，不要依赖网页判断或等待。", "history": "硝酸甘油舌下制剂在美国有长期使用历史。当前标签标示美国初始批准为 1981；FDA 于 2000-05-01 批准 NDA 021134 的 0.3、0.4、0.6 mg 压制舌下片重新配方，审评资料说明该调整旨在改善重量控制、含量均匀度和物理稳定性。当前 DailyMed 品牌标签于 2023-02 更新，并在 2024 年发布现行三个 100 片包装面板。", "sourceDocuments": [ { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_7f100d738fb4648f", "label": "FDA Drugs@FDA：NITROSTAT NDA 021134 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021134", "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_1c7f2919c4ac2cdd", "label": "FDA：NITROSTAT NDA 021134 重新配方舌下片批准信（2000-05-01）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021134（NITROSTAT nitroglycerin sublingual tablets）", "approvalTimeline": [ { "date": "1981", "title": { "zh": "当前标签所列美国初始批准", "en": "Initial U.S. approval stated in the current label" }, "detail": { "zh": "这是当前标签的历史字段；不等同于 NDA 021134 重新配方批准日期。", "en": "This is the historical field in the current label; it is not the NDA 021134 reformulation approval date." }, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2000-05-01", "title": { "zh": "FDA 批准 NDA 021134 重新配方", "en": "FDA approved the NDA 021134 reformulation" }, "detail": { "zh": "批准信涵盖 0.3、0.4、0.6 mg 舌下片；审评资料记录改进重量控制、含量均匀度与物理稳定性的目的。", "en": "The approval covers 0.3, 0.4 and 0.6 mg sublingual tablets; review records describe improvements in weight control, content uniformity and physical stability." }, "source": { "id": "src_1c7f2919c4ac2cdd", "label": "FDA：NITROSTAT NDA 021134 重新配方舌下片批准信（2000-05-01）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-02 / 2024", "title": { "zh": "当前标签修订与包装发布", "en": "Current label revision and package publication" }, "detail": { "zh": "DailyMed 标签修订于 2023-02，三个 Viatris 100 片包装记录于 2024 发布。", "en": "The DailyMed label was revised in Feb 2023, and three Viatris 100-tablet package records were published in 2024." }, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 舌下片；0.6 mg 为 RS", "en": "Current prescription RLD sublingual tablets; 0.6 mg is RS" }, "detail": { "zh": "三个 100 片原装玻璃瓶/纸盒面板已逐项建立。监管与包装记录不证明实时库存、购买资格或个人应急安排。", "en": "Three original 100-tablet glass-bottle/carton panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility or an individual's emergency plan." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌名、共同成分或 mg 数推定当地批准、包装、供应或可替代性。", "en": "No local approval, package, supply or interchangeability is inferred from a U.S. brand, shared ingredient or mg figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "硝酸甘油片是吞下去还是含在舌下？", "en": "Is a NITROSTAT tablet swallowed or placed under the tongue?" }, "answer": { "zh": "本档案的 NITROSTAT 是舌下片：标签要求放在舌下或颊囊让其溶解，不得压碎、咀嚼或吞下。其他硝酸甘油剂型不能套用这条说明。", "en": "This NITROSTAT dossier covers a sublingual tablet. The label says to place it under the tongue or in the buccal pouch and let it dissolve; do not crush, chew or swallow it. Do not transfer this instruction to another nitroglycerin form." } }, { "question": { "zh": "药片可以分装到一周药盒吗？", "en": "Can the tablets be moved into a weekly pill organiser?" }, "answer": { "zh": "标签要求保留在原装玻璃瓶并每次使用后立即拧紧，以防效价降低。不要与日常药混装；携带和更换问题请让药师按实际瓶子核对。", "en": "The label says to keep the tablets in the original glass container and tightly cap it immediately after use to prevent loss of potency. Do not mix them with routine medicines; ask a pharmacist about carrying and replacement using the actual bottle." } }, { "question": { "zh": "用了西地那非或他达拉非，还能含硝酸甘油吗？", "en": "Can NITROSTAT be used after sildenafil or tadalafil?" }, "answer": { "zh": "现行标签把 PDE-5 抑制剂与 NITROSTAT 列为禁忌联用，因为可能出现严重低血压。不要自行估算安全间隔；胸痛时立即联系急救并告知所用产品、剂量和时间。", "en": "Current labelling contraindicates PDE-5 inhibitors with NITROSTAT because severe hypotension may occur. Do not calculate a safe interval yourself. During chest pain, contact emergency services and report the exact product, amount and time taken." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/nitrostat/", "en": "https://origindrug.com/en/drugs/nitrostat/" }, "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." ] }