Monthly
US$200
Billed every month
Escitalopram Oxalate Tablets(草酸艾司西酞普兰片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 4 applications
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders18View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers35View records ↓
API companies with A status16View records ↓
Chemical-drug catalogue
Loaded records: 18 holders; 5 in the quality-and-efficacy consistency-evaluation category, and 12 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 沈阳华泰药物研究有限公司 | 沈阳福宁药业有限公司 | 国药准字H20264751 | 2026/06/10 | 10mg（按C？？H？？FN？O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 安徽九洲方圆制药有限公司 | 安徽九洲方圆制药有限公司 | 国药准字H20244517 | 2024/07/30 | 10mg[按艾司西酞普兰（C20H21FN2O）计] | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 安徽九洲方圆制药有限公司 | 安徽九洲方圆制药有限公司 | 国药准字H20244518 | 2024/07/30 | 5mg[按艾司西酞普兰（C20H21FN2O）计] | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东新华制药股份有限公司 | 新华制药（高密）有限公司 | 国药准字H20243682 | 2024/05/15 | 10mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 成都康弘药业集团股份有限公司 | 成都康弘药业集团股份有限公司 | 国药准字H20234593 | 2023/12/05 | 5mg（按C20H21FN2O计） | Not stated by source | CDE |
| 成都康弘药业集团股份有限公司 | 成都康弘药业集团股份有限公司 | 国药准字H20234592 | 2023/12/05 | 10mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 天地恒一制药股份有限公司 | 天地恒一制药股份有限公司 | 国药准字H20234063 | 2023/08/29 | 10mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 天地恒一制药股份有限公司 | 天地恒一制药股份有限公司 | 国药准字H20234062 | 2023/08/29 | 5mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 广东九瑞科技开发有限公司 | 浙江江北药业有限公司 | 国药准字H20233260 | 2023/03/07 | 10mg(按C20H21FN2O计) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 广东九瑞科技开发有限公司 | 浙江江北药业有限公司 | 国药准字H20233261 | 2023/03/07 | 20mg(按C20H21FN2O计) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20223609 | 2022/08/23 | 20mg（按艾司西酞普兰（C20H21FN2O）计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20223607 | 2022/08/23 | 5mg（按艾司西酞普兰（C20H21FN2O）计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20223608 | 2022/08/23 | 10mg（按艾司西酞普兰（C20H21FN2O）计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| Lek Pharmaceuticals d.d. | Sandoz Private Limited | 国药准字HJ20220003 | 2022/01/30 | 10mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 花园药业股份有限公司 | 花园药业股份有限公司 | 国药准字H20213474 | 2021/06/16 | 10mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 花园药业股份有限公司 | 花园药业股份有限公司 | 国药准字H20213475 | 2021/06/16 | 20mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 花园药业股份有限公司 | 花园药业股份有限公司 | 国药准字H20213473 | 2021/06/16 | 5mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江金华康恩贝生物制药有限公司 | 浙江金华康恩贝生物制药有限公司 | 国药准字H20130105 | 2021/04/20 | 5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江金华康恩贝生物制药有限公司 | 浙江金华康恩贝生物制药有限公司 | 国药准字H20130106 | 2021/04/20 | 10mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 东莞市阳之康医药有限责任公司 | 广东东阳光药业有限公司 | 国药准字H20213259 | 2021/04/07 | 15mg（按C20H21FN2O 计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 东莞市阳之康医药有限责任公司 | 广东东阳光药业有限公司 | 国药准字H20213260 | 2021/04/07 | 20mg（按C20H21FN2O 计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 东莞市阳之康医药有限责任公司 | 广东东阳光药业有限公司 | 国药准字H20213258 | 2021/04/07 | 10mg（按C20H21FN2O 计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 东莞市阳之康医药有限责任公司 | 广东东阳光药业有限公司 | 国药准字H20213257 | 2021/04/07 | 5mg（按C20H21FN2O 计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 福建海西新药创制有限公司 | 福安药业集团宁波天衡制药有限公司 | 国药准字H20213193 | 2021/03/23 | 10mg（按C20H21FN2O计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 吉林省西点药业科技发展股份有限公司 | 吉林省西点药业科技发展股份有限公司 | 国药准字H20140108 | 2020/09/25 | 按C20H21FN2O计5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 四川科伦药业股份有限公司 | 四川科伦药业股份有限公司 | 国药准字H20184142 | 2020/09/04 | 5mg(按艾司西酞普兰计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 吉林省西点药业科技发展股份有限公司 | 国药准字H20140109 | 2020/01/20 | 按C20H21FN2O计10mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20193308 | 2019/11/04 | 按艾司西酞普兰（C20H21FN2O）计10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20193300 | 2019/11/04 | 按艾司西酞普兰（C20H21FN2O）计5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| — | 山东京卫制药有限公司 | 国药准字H20103327 | 2018/09/26 | 10mg（以C20H21FN2O计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 山东京卫制药有限公司 | 国药准字H20080599 | 2018/09/26 | 5mg（以C20H21FN2O计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 山东京卫制药有限公司 | 国药准字H20103548 | 2018/09/26 | 20mg（以C20H21FN2O计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 湖南洞庭药业股份有限公司 | 国药准字H20143391 | 2018/05/14 | 10mg(以艾司西酞普兰计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 四川科伦药业股份有限公司 | 国药准字H20080788 | 2018/02/07 | 10mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| H. Lundbeck A/S | H.Lundbeck A/S | H20140121 | 2009/04/16 | 20mg | Imported originator drug (进口原研药品) | CDE |
| H. Lundbeck A/S | H.Lundbeck A/S | H20150161 | 2005/08/31 | 5mg | Imported originator drug (进口原研药品) | CDE |
| H. Lundbeck A/S | H.Lundbeck A/S | H20150163 | 2005/08/31 | 10mg | Imported originator drug (进口原研药品) | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 35 distinct approval numbers and 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 成都康弘药业集团股份有限公司 | 国药准字H20234592 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010102016 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20184142 | 5mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010102180 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20080788 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010102292 | NHSA |
| 吉林省西点药业科技发展股份有限公司 | 国药准字H20140109 | 10mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010103454 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001010104111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223607 | 5mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001010104152 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20243682 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010104187 | NHSA |
| 福建海西新药创制股份有限公司 | 国药准字H20213193 | 10mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010104561 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20213473 | 5mg(以C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010104646 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193308 | 按艾司西酞普兰(C20H21FN2O)计10mg | Category A (甲) | XN06ABA225A001010104647 | NHSA |
| 浙江海森药业股份有限公司 | 国药准字H20130106 | 10mg | Category A (甲) | XN06ABA225A001010104656 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H20143391 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010104917 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20213257 | 5mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010106988 | NHSA |
| H. Lundbeck A/S | 国药准字HJ20150163 | 10mg [按艾司西酞普兰(C₂₀H₂₁FN₂O)计] | Category A (甲) | XN06ABA225A001010178996 | NHSA |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003 | 10mg(按C20H21FN20计) | Category A (甲) | XN06ABA225A001010179428 | NHSA |
| 天地恒一制药股份有限公司 | 国药准字H20234062 | 5mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010180086 | NHSA |
| 哈尔滨珍宝制药有限公司 | 国药准字H20244517 | 10mg[按艾司西酞普兰(C₂₀H₂₁FN₂O)计] | Category A (甲) | XN06ABA225A001010181400 | NHSA |
| 广东九瑞科技开发有限公司 | 国药准字H20233260 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010183254 | NHSA |
| 沈阳华泰药物研究有限公司 | 国药准字H20264751 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010183285 | NHSA |
| 山东普瑞曼药业有限公司 | 国药准字H20263660 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010184621 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234592 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010202016 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20184142 | 5mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010202180 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20080788 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010202292 | NHSA |
| 吉林省西点药业科技发展股份有限公司 | 国药准字H20140109 | 10mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010203454 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001010204111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223607 | 5mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001010204152 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20243682 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010204187 | NHSA |
| 福建海西新药创制股份有限公司 | 国药准字H20213193 | 10mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010204561 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20213473 | 5mg(以C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010204646 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193308 | 按艾司西酞普兰(C20H21FN2O)计10mg | Category A (甲) | XN06ABA225A001010204647 | NHSA |
| 浙江海森药业股份有限公司 | 国药准字H20130106 | 10mg | Category A (甲) | XN06ABA225A001010204656 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H20143391 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010204917 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20213257 | 5mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010206988 | NHSA |
| H. Lundbeck A/S | 国药准字HJ20150163 | 10mg [按艾司西酞普兰(C₂₀H₂₁FN₂O)计] | Category A (甲) | XN06ABA225A001010278996 | NHSA |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003 | 10mg(按C20H21FN20计) | Category A (甲) | XN06ABA225A001010279428 | NHSA |
| 广东九瑞科技开发有限公司 | 国药准字H20233260 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010283254 | NHSA |
| 山东普瑞曼药业有限公司 | 国药准字H20263660 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010284621 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234592 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010302016 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20184142 | 5mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010302180 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20080788 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010302292 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001010304111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223607 | 5mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001010304152 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20243682 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010304187 | NHSA |
| 福建海西新药创制股份有限公司 | 国药准字H20213193 | 10mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001010304561 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20213473 | 5mg(以C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010304646 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193308 | 按艾司西酞普兰(C20H21FN2O)计10mg | Category A (甲) | XN06ABA225A001010304647 | NHSA |
| 浙江海森药业股份有限公司 | 国药准字H20130106 | 10mg | Category A (甲) | XN06ABA225A001010304656 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H20143391 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010304917 | NHSA |
| 广东九瑞科技开发有限公司 | 国药准字H20233260 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010383254 | NHSA |
| 山东普瑞曼药业有限公司 | 国药准字H20263660 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010384621 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234592 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010402016 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20184142 | 5mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010402180 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20080788 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010402292 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001010404111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223607 | 5mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001010404152 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193308 | 按艾司西酞普兰(C20H21FN2O)计10mg | Category A (甲) | XN06ABA225A001010404647 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H20143391 | 10mg(按艾司西酞普兰计) | Category A (甲) | XN06ABA225A001010404917 | NHSA |
| 山东普瑞曼药业有限公司 | 国药准字H20263660 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010484621 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001010504111 | NHSA |
| 山东普瑞曼药业有限公司 | 国药准字H20263660 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010584621 | NHSA |
| 山东普瑞曼药业有限公司 | 国药准字H20263660 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001010684621 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234593 | 5mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020102016 | NHSA |
| 吉林省西点药业科技发展股份有限公司 | 国药准字H20140108 | 5mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001020103454 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103548 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001020104111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223608 | 10mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001020104152 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20213474 | 10mg(以C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020104646 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193300 | 按艾司西酞普兰(C20H21FN2O)计5mg | Category A (甲) | XN06ABA225A001020104647 | NHSA |
| 浙江海森药业股份有限公司 | 国药准字H20130105 | 5mg | Category A (甲) | XN06ABA225A001020104656 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20213258 | 10mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001020106988 | NHSA |
| H.Lundbeck A/S | H20150161 | 5mg[按艾司西酞普兰(C20H21FN2O)计] | Category A (甲) | XN06ABA225A001020178996 | NHSA |
| 天地恒一制药股份有限公司 | 国药准字H20234063 | 10mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020180086 | NHSA |
| 哈尔滨珍宝制药有限公司 | 国药准字H20244518 | 5mg[按艾司西酞普兰(C₂₀H₂₁FN₂O)计] | Category A (甲) | XN06ABA225A001020181400 | NHSA |
| 广东九瑞科技开发有限公司 | 国药准字H20233261 | 20mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020183254 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234593 | 5mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020202016 | NHSA |
| 吉林省西点药业科技发展股份有限公司 | 国药准字H20140108 | 5mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001020203454 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103548 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001020204111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223608 | 10mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001020204152 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20213474 | 10mg(以C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020204646 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193300 | 按艾司西酞普兰(C20H21FN2O)计5mg | Category A (甲) | XN06ABA225A001020204647 | NHSA |
| 浙江海森药业股份有限公司 | 国药准字H20130105 | 5mg | Category A (甲) | XN06ABA225A001020204656 | NHSA |
| H.Lundbeck A/S | H20150161 | 5mg[按艾司西酞普兰(C20H21FN2O)计] | Category A (甲) | XN06ABA225A001020278996 | NHSA |
| 广东九瑞科技开发有限公司 | 国药准字H20233261 | 20mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020283254 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234593 | 5mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020302016 | NHSA |
| 吉林省西点药业科技发展股份有限公司 | 国药准字H20140108 | 5mg(按C20H21FN2O计) | Category A (甲) | XN06ABA225A001020303454 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103548 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001020304111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223608 | 10mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001020304152 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20213474 | 10mg(以C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020304646 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20193300 | 按艾司西酞普兰(C20H21FN2O)计5mg | Category A (甲) | XN06ABA225A001020304647 | NHSA |
| 广东九瑞科技开发有限公司 | 国药准字H20233261 | 20mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020383254 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20234593 | 5mg(按C₂₀H₂₁FN₂O计) | Category A (甲) | XN06ABA225A001020402016 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223608 | 10mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001020404152 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030104111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223609 | 20mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001030104152 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20213475 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030104646 | NHSA |
| 浙江海森药业股份有限公司 | 国药准字H20130106 | 10mg | Category A (甲) | XN06ABA225A001030104656 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030204111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223609 | 20mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001030204152 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20213475 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030204646 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030304111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223609 | 20mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001030304152 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030404111 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20223609 | 20mg(按艾司西酞普兰(C₂₀H₂₁FN₂O)计) | Category A (甲) | XN06ABA225A001030404152 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030504111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030604111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001030704111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001040104111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001050104111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001050204111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103327 | 10mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001050304111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103548 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001060104111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20103548 | 20mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001060204111 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20080599 | 5mg(以C20H21FN2O计) | Category A (甲) | XN06ABA225A001070104111 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 6 filings and 3 distinct first applicants.
Generic 4 · Import 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 上海现代制药股份有限公司 | CYHS2602144 | Generic | 2026/08/27 | Not stated by source | CDE |
| 上海现代制药股份有限公司 | CYHS2602143 | Generic | 2026/08/27 | Not stated by source | CDE |
| 武汉人福药业有限责任公司 | CYHS2602037 | Generic | 2026/08/18 | Not stated by source | CDE |
| 武汉人福药业有限责任公司 | CYHS2602036 | Generic | 2026/08/18 | Not stated by source | CDE |
| Maxmind Pharmaceutical S.L.;Macleods Pharmaceuticals Ltd.;Maxmind Biotechnology (Hainan) Co. Ltd. | JYHS2400060 | Import | 2024/12/05 | Not stated by source | CDE |
| Maxmind Pharmaceutical S.L.;Macleods Pharmaceuticals Ltd.;Maxmind Biotechnology (Hainan) Co. Ltd. | JYHS2400059 | Import | 2024/12/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 上海现代制药股份有限公司 | CYHS2602144 | Generic | 2026/08/27 | Not stated by source | CDE |
| 上海现代制药股份有限公司 | CYHS2602143 | Generic | 2026/08/27 | Not stated by source | CDE |
| 武汉人福药业有限责任公司 | CYHS2602037 | Generic | 2026/08/18 | Not stated by source | CDE |
| 武汉人福药业有限责任公司 | CYHS2602036 | Generic | 2026/08/18 | Not stated by source | CDE |
API registrations
Non-component matches: 16 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 草酸艾司西酞普兰 | 上海锦帝九州药业（安阳）有限公司 | Y20260000777 | I | Exact ingredient | 2026/09/10 | CDE |
| 草酸艾司西酞普兰 | 湖北葛店人福药业有限责任公司 | Y20260000275 | I | Exact ingredient | 2026/04/29 | CDE |
| 草酸艾司西酞普兰 | Virupaksha Organics Limited | Y20240000675 | A | Exact ingredient | 2026/04/21 | CDE |
| 草酸艾司西酞普兰 | Hetero Labs Limited | Y20210001164 | A | Exact ingredient | 2024/12/29 | CDE |
| 草酸艾司西酞普兰 | 万全万特制药（厦门）有限公司 | Y20200000363 | I | Exact ingredient | 2020/05/15 | CDE |
| 草酸艾司西酞普兰 | Olon S.p.A. | Y20190021297 | A | Exact ingredient | 2022/10/27 | CDE |
| 草酸艾司西酞普兰 | 山东锐顺药业有限公司 | Y20190009855 | A | Exact ingredient | 2024/01/17 | CDE |
| 草酸艾司西酞普兰 | 浙江华海药业股份有限公司 | Y20190009839 | A | Exact ingredient | 2026/05/20 | CDE |
| 草酸艾司西酞普兰 | 四川科伦药业股份有限公司 | Y20190008922 | A | Exact ingredient | 2024/07/26 | CDE |
| 草酸艾司西酞普兰 | 山东安信制药有限公司 | Y20190008896 | A | Exact ingredient | 2024/04/30 | CDE |
| 草酸艾司西酞普兰 | 浙江海森药业股份有限公司 | Y20190007282 | A | Exact ingredient | 2023/08/16 | CDE |
| 草酸艾司西酞普兰 | 无锡积大制药有限公司 | Y20190006965 | A | Exact ingredient | 2023/03/24 | CDE |
| 草酸艾司西酞普兰 | 湖南洞庭药业股份有限公司 | Y20190001441 | A | Exact ingredient | 2024/10/18 | CDE |
| 草酸艾司西酞普兰 | 吉林省西点药业科技发展股份有限公司 | Y20190001382 | A | Exact ingredient | 2025/08/09 | CDE |
| 草酸艾司西酞普兰 | 浙江华海药业股份有限公司 | Y20180001104 | A | Exact ingredient | 2026/05/20 | CDE |
| 草酸艾司西酞普兰 | 山东锐顺药业有限公司 | Y20170001891 | A | Exact ingredient | 2024/09/26 | CDE |
| 草酸艾司西酞普兰 | 山东新华制药股份有限公司 | Y20170001449 | A | Exact ingredient | 2024/02/08 | CDE |
| 草酸艾司西酞普兰 | 上海现代制药股份有限公司 | Y20170001293 | A | Exact ingredient | 2024/01/18 | CDE |
| 草酸艾司西酞普兰 | 瑞阳制药股份有限公司 | Y20170001283 | A | Exact ingredient | 2025/01/03 | CDE |
| 草酸艾司西酞普兰 | 乳源东阳光药业有限公司 | Y20170000762 | A | Exact ingredient | 2023/08/10 | CDE |
| 草酸艾司西酞普兰 | 万全万特制药江苏有限公司 | Y20170000654 | A | Exact ingredient | 2023/03/24 | CDE |
| 草酸艾司西酞普兰 | 辰欣药业股份有限公司 | Y20170000637 | I | Exact ingredient | — | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
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2026/08/27Accepted
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2026/08/27Accepted
-
2026/08/18Accepted
-
2026/08/18Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/10 07:25
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 3/30; discovered pending details: 20. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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