Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationNo longer listed under review: 1 applicationSupplement delivery: 2 applications
Current coverage may be incomplete
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.
Loaded records: 25 holders; 9 in the quality-and-efficacy consistency-evaluation category, and 13 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 |
|---|---|---|---|---|---|---|
| 湖南九典制药股份有限公司 | 湖南九典制药股份有限公司 | 国药准字H20266048 | 2026/09/22 | 0.1g(按C38H72N2O12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 |
| 浙江中同药业有限公司 | 浙江中同药业有限公司 | 国药准字H20263577 | 2026/03/10 | 0.1g(按C38H72N2O12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 |
| 北京四环科宝制药股份有限公司 | 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 2026/02/25 | 0.1g(按C38H72N2O12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 |
| 上海现代制药股份有限公司 | 上海现代制药股份有限公司 | 国药准字H20041281 | 2025/06/24 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 河南比福制药股份有限公司 | 河南比福制药股份有限公司 | 国药准字H20249812 | 2024/12/25 | 0.1g(按C38H72N2O12计) | Not stated by source | CDE |
| 海南斯达制药有限公司 | 海南赛立克药业有限公司 | 国药准字H20249741 | 2024/12/17 | 0.1g(按C38H72N2O12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 |
| 迪沙药业集团有限公司 | 迪沙药业集团有限公司 | 国药准字H20249662 | 2024/12/01 | 0.1g(按C38H72N2O12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 |
| 山东淄博新达制药有限公司 | 山东淄博新达制药有限公司 | 国药准字H20094126 | 2024/11/29 | 0.1g(按 C38H72N2O12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 |
| 长春海悦药业股份有限公司 | 长春海悦药业股份有限公司 | 国药准字H20244817 | 2024/09/03 | 0.1g(以C38H72N2O12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 |
| 宜昌东阳光长江药业股份有限公司 | 宜昌东阳光长江药业股份有限公司 | 国药准字H20057591 | 2024/09/02 | 0.1g(按C38H72N2O12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 |
| 四川百利药业有限责任公司 | 四川百利药业有限责任公司 | 国药准字H20244232 | 2024/06/28 | 0.1g(按C38H72N2O12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H20244181 | 2024/06/28 | 0.1g(以C38H72N2O12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 |
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20234224 | 2023/09/28 | 0.1g(按C38H72N2O12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 |
| 宜昌人福药业有限责任公司 | 宜昌人福药业有限责任公司 | 国药准字H20234182 | 2023/09/19 | 0.1g(按C38H72N2O12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 |
| 济川药业集团有限公司 | 济川药业集团有限公司 | 国药准字H20233759 | 2023/06/21 | 0.1g(按C38H72N2O12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 |
| 吉林四环制药有限公司 | 吉林四环制药有限公司 | 国药准字H20233566 | 2023/05/19 | 0.1g(按C38H72N2O12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 |
| 江西赣南海欣药业股份有限公司 | 江西赣南海欣药业股份有限公司 | 国药准字H20093669 | 2023/03/22 | 0.1g(按C38H72N2O12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 |
| 海南普利制药股份有限公司 | 浙江普利药业有限公司 | 国药准字H20237002 | 2023/01/18 | 100mg/5mL | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南普利制药股份有限公司 | 浙江普利药业有限公司 | 国药准字H20237007 | 2023/01/18 | 200mg/5mL | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 石药集团欧意药业有限公司 | 石药集团欧意药业有限公司 | 国药准字H10980217 | 2023/01/18 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南普利制药股份有限公司 | 浙江普利药业有限公司 | 国药准字H20057604 | 2023/01/18 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 苏州东瑞制药有限公司 | 苏州东瑞制药有限公司 | 国药准字H20058153 | 2022/12/26 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 西安利君制药有限责任公司 | 西安利君制药有限责任公司 | 国药准字H20083443 | 2022/10/27 | 0.1g(按C38H72N2O12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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20223641 | 2022/08/30 | 0.1g(按C38H72N2O12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 |
| — | 辉瑞制药有限公司 | 国药准字H10960112 | 1995/08/21 | 0.1g(按C38H72N2O12计) | Other drug (其他药品) | CDE |
| Pliva Croatia Ltd. | Pliva Croatia Ltd. | H20160584 | 1994/03/13 | 100mg/5ml | Imported originator drug (进口原研药品) | CDE |
| Pliva Croatia Ltd. | Pliva Croatia Ltd. | H20160585;H20160614 | 1994/03/13 | 200mg/5ml | Imported originator drug (进口原研药品) | CDE |
| 浙江康德药业集团股份有限公司 | 浙江康德药业集团股份有限公司 | 国药准字H20066930 | 2026/11/02 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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.
Loaded records: 48 distinct approval numbers and 39 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 首儿药业(北京)有限公司 | 国药准字H20084530 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010100138 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010100151 | NHSA |
| 国药集团汕头金石制药有限公司 | 国药准字H20059064 | 0.1g | Category B (乙) | XJ01FAA051X006010100480 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20041281 | 0.1g(按C38H72N2O12计) | Category B (乙) | XJ01FAA051X006010100785 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H20073900 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010101161 | NHSA |
| 辉瑞制药科技有限公司 | 国药准字H10960112 | 0.1g(按C38H72N2012计) | Category B (乙) | XJ01FAA051X006010101187 | NHSA |
| 济川药业集团有限公司 | 国药准字H20233759 | 0.1g(按C38H72N2O12计) | Category B (乙) | XJ01FAA051X006010101453 | NHSA |
| 南通久和药业有限公司 | 国药准字H20065329 | 0.1g | Category B (乙) | XJ01FAA051X006010101623 | NHSA |
| 苏州东瑞制药有限公司 | 国药准字H20058153 | 0.1g | Category B (乙) | XJ01FAA051X006010101650 | NHSA |
| 宜昌东阳光长江药业股份有限公司 | 国药准字H20057591 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010101997 | NHSA |
| 宜昌人福药业有限责任公司 | 国药准字H20234182 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010102000 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20234224 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010102013 | NHSA |
| 四川百利药业有限责任公司 | 国药准字H20244232 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010102120 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010102297 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H20083443 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010102503 | NHSA |
| 葵花药业集团(衡水)得菲尔有限公司 | 国药准字H20063830 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010102621 | NHSA |
| 石家庄市华新药业有限责任公司 | 国药准字H20073728 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010102753 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010102763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010102770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010103307 | NHSA |
| 吉林四环制药有限公司 | 国药准字H20233566 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010103492 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010103628 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006010103706 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010104140 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20244181 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010104152 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006010104203 | NHSA |
| 浙江爱诺生物药业股份有限公司 | 国药准字H20083832 | 0.1g | Category B (乙) | XJ01FAA051X006010104617 | NHSA |
| 浙江康德药业集团股份有限公司 | 国药准字H20066930 | 0.1g | Category B (乙) | XJ01FAA051X006010104669 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20057207 | 0.1g | Category B (乙) | XJ01FAA051X006010104914 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H20093669 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010105283 | NHSA |
| 江西红星药业有限公司 | 国药准字H20064805 | 0.1g | Category B (乙) | XJ01FAA051X006010105295 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010105801 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20249741 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010105816 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010105826 | NHSA |
| Pliva Croatia Ltd. | H20160585 | 200mg/5ml | Category B (乙) | XJ01FAA051X006010179335 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249812 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010183004 | NHSA |
| 浙江中同药业有限公司 | 国药准字H20263577 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010184243 | NHSA |
| 达嘉维康生物制药有限公司 | 国药准字H20264545 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010184377 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010200151 | NHSA |
| 国药集团汕头金石制药有限公司 | 国药准字H20059064 | 0.1g | Category B (乙) | XJ01FAA051X006010200480 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H20073900 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010201161 | NHSA |
| 辽宁新高制药有限公司 | 国药准字H20057713 | 0.1g | Category B (乙) | XJ01FAA051X006010201288 | NHSA |
| 南通久和药业有限公司 | 国药准字H20065329 | 0.1g | Category B (乙) | XJ01FAA051X006010201623 | NHSA |
| 苏州东瑞制药有限公司 | 国药准字H20058153 | 0.1g | Category B (乙) | XJ01FAA051X006010201650 | NHSA |
| 宜昌东阳光长江药业股份有限公司 | 国药准字H20057591 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010201997 | NHSA |
| 宜昌人福药业有限责任公司 | 国药准字H20234182 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010202000 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20234224 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010202013 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010202297 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H20083443 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010202503 | NHSA |
| 葵花药业集团(衡水)得菲尔有限公司 | 国药准字H20063830 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010202621 | NHSA |
| 石家庄市华新药业有限责任公司 | 国药准字H20073728 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010202753 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010202763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010202770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010203307 | NHSA |
| 吉林四环制药有限公司 | 国药准字H20233566 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010203492 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010203628 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006010203706 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010204140 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006010204203 | NHSA |
| 浙江爱诺生物药业股份有限公司 | 国药准字H20083832 | 0.1g | Category B (乙) | XJ01FAA051X006010204617 | NHSA |
| 浙江康德药业集团股份有限公司 | 国药准字H20066930 | 0.1g | Category B (乙) | XJ01FAA051X006010204669 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20057207 | 0.1g | Category B (乙) | XJ01FAA051X006010204914 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H20093669 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010205283 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010205801 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20249741 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010205816 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010205826 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249812 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010283004 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010300151 | NHSA |
| 辽宁新高制药有限公司 | 国药准字H20057713 | 0.1g | Category B (乙) | XJ01FAA051X006010301288 | NHSA |
| 南通久和药业有限公司 | 国药准字H20065329 | 0.1g | Category B (乙) | XJ01FAA051X006010301623 | NHSA |
| 苏州东瑞制药有限公司 | 国药准字H20058153 | 0.1g | Category B (乙) | XJ01FAA051X006010301650 | NHSA |
| 宜昌人福药业有限责任公司 | 国药准字H20234182 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010302000 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20234224 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010302013 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010302297 | NHSA |
| 葵花药业集团(衡水)得菲尔有限公司 | 国药准字H20063830 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010302621 | NHSA |
| 石家庄市华新药业有限责任公司 | 国药准字H20073728 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010302753 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010302763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010302770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010303307 | NHSA |
| 吉林四环制药有限公司 | 国药准字H20233566 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010303492 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010303628 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006010303706 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010304140 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006010304203 | NHSA |
| 浙江康德药业集团股份有限公司 | 国药准字H20066930 | 0.1g | Category B (乙) | XJ01FAA051X006010304669 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20057207 | 0.1g | Category B (乙) | XJ01FAA051X006010304914 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H20093669 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010305283 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010305801 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20249741 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010305816 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010305826 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249812 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010383004 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010400151 | NHSA |
| 辽宁新高制药有限公司 | 国药准字H20057713 | 0.1g | Category B (乙) | XJ01FAA051X006010401288 | NHSA |
| 南通久和药业有限公司 | 国药准字H20065329 | 0.1g | Category B (乙) | XJ01FAA051X006010401623 | NHSA |
| 苏州东瑞制药有限公司 | 国药准字H20058153 | 0.1g | Category B (乙) | XJ01FAA051X006010401650 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010402297 | NHSA |
| 石家庄市华新药业有限责任公司 | 国药准字H20073728 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010402753 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010402763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010402770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010403307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010403628 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010404140 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006010404203 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010405801 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010405826 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010500151 | NHSA |
| 南通久和药业有限公司 | 国药准字H20065329 | 0.1g | Category B (乙) | XJ01FAA051X006010501623 | NHSA |
| 苏州东瑞制药有限公司 | 国药准字H20058153 | 0.1g | Category B (乙) | XJ01FAA051X006010501650 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010502297 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010502763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010502770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010503307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010503628 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010504140 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006010504203 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010505801 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010505826 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010600151 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010602297 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010602763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010602770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010603307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010603628 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010604140 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010605801 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010605826 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263438 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010700151 | NHSA |
| 四川制药制剂有限公司 | 国药准字H20083473 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006010702297 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010702763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006010702770 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010703307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010703628 | NHSA |
| 山东绿因药业有限公司 | 国药准字H20059971 | 0.1g | Category B (乙) | XJ01FAA051X006010704140 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010705801 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074238 | 0.125g | Category B (乙) | XJ01FAA051X006010705826 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010802763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010803307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010803628 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20057604 | 0.1g | Category B (乙) | XJ01FAA051X006010805801 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010902763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006010903307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006010903628 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011002763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011003307 | NHSA |
| 哈尔滨儿童制药厂有限公司 | 国药准字H20103048 | 0.1g | Category B (乙) | XJ01FAA051X006011003628 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011102763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011103307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011202763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011203307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011302763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011303307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011402763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011403307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011502763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011503307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011602763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011603307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011702763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011703307 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223641 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011802763 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011803307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006011903307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012003307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012103307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012203307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012303307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012403307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012503307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012603307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20244817 | 0.1g(以C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006012703307 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H20073900 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006020101161 | NHSA |
| 辉瑞制药科技有限公司 | 国药准字H10960112 | 0.1g(按C38H72N2012计) | Category B (乙) | XJ01FAA051X006020101187 | NHSA |
| 宜昌东阳光长江药业股份有限公司 | 国药准字H20057591 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006020101997 | NHSA |
| 葵花药业集团(衡水)得菲尔有限公司 | 国药准字H20063830 | 0.1g(10万单位) | Category B (乙) | XJ01FAA051X006020102621 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20046654 | 0.125g(12.5万单位) | Category B (乙) | XJ01FAA051X006020102770 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020103706 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006020104203 | NHSA |
| 浙江爱诺生物药业股份有限公司 | 国药准字H20083832 | 0.1g | Category B (乙) | XJ01FAA051X006020104617 | NHSA |
| 浙江康德药业集团股份有限公司 | 国药准字H20066930 | 0.1g | Category B (乙) | XJ01FAA051X006020104669 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20057207 | 0.1g | Category B (乙) | XJ01FAA051X006020104914 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20237007 | 200mg/5mL | Category B (乙) | XJ01FAA051X006020105801 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020105826 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020203706 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020205826 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020303706 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020305826 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020403706 | NHSA |
| 浙江康德药业集团股份有限公司 | 国药准字H20066930 | 0.1g | Category B (乙) | XJ01FAA051X006020404669 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020405826 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020503706 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006020504203 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020505826 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020603706 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006020604203 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020605826 | NHSA |
| 黑龙江诺捷制药有限责任公司 | 国药准字H20057332 | 0.1g | Category B (乙) | XJ01FAA051X006020703706 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020705826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020805826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006020905826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006021005826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006021105826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006021205826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20057649 | 0.1g | Category B (乙) | XJ01FAA051X006021305826 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20046655 | 0.25g(25万单位) | Category B (乙) | XJ01FAA051X006030102770 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006030104203 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20057207 | 0.1g | Category B (乙) | XJ01FAA051X006030104914 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H20093669 | 0.1g(按C₃₈H₇₂N₂O₁₂计) | Category B (乙) | XJ01FAA051X006030105283 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20237007 | 200mg/5mL | Category B (乙) | XJ01FAA051X006030105801 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030105826 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160584 | 100mg/5ml | Category B (乙) | XJ01FAA051X006030179335 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030205826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030305826 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20057207 | 0.1g | Category B (乙) | XJ01FAA051X006030404914 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030405826 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030505826 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006030604203 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030605826 | NHSA |
| 山东淄博新达制药有限公司 | 国药准字H20094126 | 0.1g | Category B (乙) | XJ01FAA051X006030704203 | NHSA |
| 海南全星制药有限公司 | 国药准字H20074239 | 0.25g | Category B (乙) | XJ01FAA051X006030705826 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10980217 | 0.1g | Category B (乙) | XJ01FAA051X006040102770 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20237002 | 100mg/5mL | Category B (乙) | XJ01FAA051X006040105801 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160585 | 200mg/5ml | Category B (乙) | XJ01FAA051X006040179335 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160585 | 200mg/5ml | Category B (乙) | XJ01FAA051X006050179335 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160614 | 200mg/5ml | Category B (乙) | XJ01FAA051X006060179335 | 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.
Loaded records: 8 filings and 7 distinct first applicants.
Generic 4 · Supplement 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏万高药业股份有限公司 | CYHS2600122 | Generic | 2026/01/09 | Not stated by source | CDE |
| 山东鲁抗医药集团赛特有限责任公司 | CYHS2601965 | Generic | 2026/08/11 | Not stated by source | CDE |
| 南通久和药业有限公司 | CYHB2650166 | Supplement | 2026/07/27 | Not stated by source | CDE |
| 四川制药制剂有限公司 | CYHB2550346 | Supplement | 2025/10/22 | Not stated by source | CDE |
| 广东方盛健盟药业有限公司 | CYHS2503630 | Generic | 2025/10/11 | Not stated by source | CDE |
| 海南全星制药有限公司 | CYHB2550300 | Supplement | 2025/08/22 | Not stated by source | CDE |
| 四川制药制剂有限公司 | CYHB2501395 | Supplement | 2025/07/14 | Not stated by source | CDE |
| 山东普瑞曼药业有限公司 | CYHS2502380 | Generic | 2025/07/05 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
Non-component matches: 34 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 |
|---|---|---|---|---|---|---|
| 阿奇霉素 | 浙江金华康恩贝生物制药有限公司 | Y20260000882 | I | Exact ingredient | 2026/10/21 | CDE |
| 阿奇霉素 | Pharmagen Ltd. | Y20250000419 | I | Exact ingredient | 2025/07/11 | CDE |
| 阿奇霉素 | Alembic Pharmaceuticals Limited | Y20240000887 | A | Exact ingredient | 2026/09/03 | CDE |
| 阿奇霉素 | 宁夏泰益欣生物科技股份有限公司 | Y20210000368 | A | Exact ingredient | 2026/03/02 | CDE |
| 阿奇霉素 | Pfizer Asia Manufacturing Pte Ltd | Y20200001087 | A | Exact ingredient | 2024/09/10 | CDE |
| 阿奇霉素 | 湖南九典宏阳制药有限公司 | Y20180001793 | A | Exact ingredient | 2023/10/17 | CDE |
| 阿奇霉素 | TAPI Croatia Industries Ltd. | Y20190009959 | A | Exact ingredient | 2025/10/30 | CDE |
| 阿奇霉素 | 浙江国邦药业有限公司 | Y20190009898 | A | Exact ingredient | 2024/07/03 | CDE |
| 阿奇霉素 | 石药集团欧意药业有限公司 | Y20190009555 | A | Exact ingredient | 2024/07/09 | CDE |
| 阿奇霉素 | Pfizer Inc. | Y20190009141 | A | Exact ingredient | 2024/11/12 | CDE |
| 阿奇霉素 | 江苏威奇达药业有限公司 | Y20190008874 | A | Exact ingredient | 2026/08/06 | CDE |
| 阿奇霉素 | 黄石世星药业有限责任公司 | Y20190008850 | A | Exact ingredient | 2026/02/07 | CDE |
| 阿奇霉素 | 浙江震元制药有限公司 | Y20190007600 | A | Exact ingredient | 2024/06/12 | CDE |
| 阿奇霉素 | 开封制药(集团)有限公司 | Y20190006536 | A | Exact ingredient | 2025/07/23 | CDE |
| 阿奇霉素 | 天方药业有限公司 | Y20190006317 | A | Exact ingredient | 2024/11/01 | CDE |
| 阿奇霉素 | 宁夏启元药业有限公司 | Y20190006173 | A | Exact ingredient | 2026/03/19 | CDE |
| 阿奇霉素 | 西安利君制药有限责任公司 | Y20190005668 | A | Exact ingredient | 2026/01/07 | CDE |
| 阿奇霉素 | 北京太洋药业股份有限公司 | Y20190005484 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 宜昌东阳光生化制药有限公司 | Y20190005339 | A | Exact ingredient | 2026/02/13 | CDE |
| 阿奇霉素 | 河北东风药业有限公司 | Y20190004976 | A | Exact ingredient | 2025/02/09 | CDE |
| 阿奇霉素 | 浙江贝得药业有限公司 | Y20190004814 | A | Exact ingredient | 2025/03/04 | CDE |
| 马来酸阿奇霉素 | 天津生物化学制药有限公司 | Y20190004393 | A | Salt-normalized ingredient | 2025/08/16 | CDE |
| 阿奇霉素 | 台山市化学制药有限公司 | Y20190004081 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 华北制药河北华民药业有限责任公司 | Y20190003842 | A | Exact ingredient | 2025/06/07 | CDE |
| 阿奇霉素 | 菏泽市方明制药有限公司 | Y20190003689 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 浙江耐司康药业有限公司 | Y20190003585 | A | Exact ingredient | 2025/07/05 | CDE |
| 阿奇霉素 | 浙江奥托康制药集团股份有限公司 | Y20190003518 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 浙江永宁药业股份有限公司 | Y20190003427 | A | Exact ingredient | 2024/12/10 | CDE |
| 盐酸阿奇霉素 | 南京长澳制药有限公司 | Y20190002838 | A | Salt-normalized ingredient | — | CDE |
| 硫酸阿奇霉素 | 浙江尖峰药业有限公司 | Y20190002579 | A | Salt-normalized ingredient | 2024/11/20 | CDE |
| 富马酸阿奇霉素 | 德州德药制药有限公司 | Y20190002300 | A | Salt-normalized ingredient | 2025/02/07 | CDE |
| 阿奇霉素 | 齐鲁制药有限公司 | Y20190001577 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 绍兴兴亚药业有限公司 | Y20190001524 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 四川江川制药有限公司 | Y20190001366 | A | Exact ingredient | — | CDE |
| 阿奇霉素 | 乳源东阳光药业有限公司 | Y20190000922 | A | Exact ingredient | 2023/08/14 | CDE |
| 阿奇霉素 | 石药集团欧意药业有限公司 | Y20190000443 | I | Exact ingredient | 2019/06/12 | CDE |
| 阿奇霉素 | PLIVA Croatia Ltd. | Y20180001512 | I | Exact ingredient | 2019/02/03 | CDE |
| 阿奇霉素 | 河北国龙制药有限公司 | Y20170000182 | A | Exact ingredient | 2024/10/24 | 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.
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.
CYHB2501395
Fact date: 2026/11/09 · Publication date: 2026/11/10 · Site observation date: 2026/11/10
Supplemental application; excluded from new marketing approvals.
View source · Table row 4 ↗CYHB2550339
Fact date: 2026/11/04 · Site observation date: 2026/11/04
Accepted: 2025/10/16
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/03 (approval no.: —; approval date: 2026/11/02); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 3
NMPA · Table row 3 ↗ View source ↗CYHB2550339
Fact date: 2026/11/02 · Publication date: 2026/11/03 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 3 ↗CYHS2501185 · 国药准字H20266378
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 46 ↗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.
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.
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.
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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