Monthly
US$200
Billed every month
西格列汀二甲双胍片(II)
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 2 applicationsSupplement delivery: 2 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 holders25View records ↓
Under-review filings5View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers25View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 25 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 24 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 |
|---|---|---|---|---|---|---|
| 新石阳光药业（河北）有限公司 | 新石阳光药业（河北）有限公司 | 国药准字H20264418 | 2026/05/19 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 湖北午时医药研究院有限公司 | 湖北午时药业股份有限公司 | 国药准字H20263985 | 2026/04/14 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 石家庄市华新药业有限责任公司 | 石家庄市华新药业有限责任公司 | 国药准字H20264003 | 2026/04/14 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 甘李药业山东有限公司 | 甘李药业山东有限公司 | 国药准字H20263765 | 2026/03/31 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 北京双鹭药业股份有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20263692 | 2026/03/25 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 湖南威特制药股份有限公司 | 湖南威特制药股份有限公司 | 国药准字H20255797 | 2025/10/28 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 浙江永太药业有限公司 | 浙江永太药业有限公司 | 国药准字H20253199 | 2025/01/14 | 每片含磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍850mg（以C4H11N5·HCl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 |
| 江苏康缘药业股份有限公司 | 江苏康缘药业股份有限公司 | 国药准字H20253074 | 2025/01/08 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 浙江英格莱制药有限公司 | 浙江英格莱制药有限公司 | 国药准字H20249536 | 2024/12/01 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 浙江诺得药业有限公司 | 浙江诺得药业有限公司 | 国药准字H20244899 | 2024/09/19 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 吉林长白山药业集团股份有限公司 | 吉林长白山药业集团股份有限公司 | 国药准字H20244780 | 2024/09/03 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 浙江恒研医药科技有限公司 | 浙江赛默制药有限公司 | 国药准字H20244159 | 2024/06/25 | 每片含磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍850mg（以C4H11N5·HCl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 |
| 惠升生物制药股份有限公司 | 天津汉瑞药业有限公司 | 国药准字H20243802 | 2024/05/21 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 江苏德源药业股份有限公司 | 江苏德源药业股份有限公司 | 国药准字H20243710 | 2024/05/15 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg。 | 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 |
| 宁波美诺华天康药业有限公司 | 宁波美诺华天康药业有限公司 | 国药准字H20243712 | 2024/05/15 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 济南辰欣医药科技有限公司 | 辰欣药业股份有限公司 | 国药准字H20243568 | 2024/04/24 | 每片含磷酸西格列汀50mg（按C16H15F6N5O计）和盐酸二甲双胍850mg | 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 |
| 浙江九洲生物医药有限公司 | 山东朗诺制药有限公司 | 国药准字H20243400 | 2024/03/29 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | 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 |
| 齐鲁制药（海南）有限公司 | 齐鲁制药（海南）有限公司 | 国药准字H20233804 | 2023/06/27 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 深圳翰宇药业股份有限公司 | 深圳翰宇药业股份有限公司 | 国药准字H20233025 | 2023/01/10 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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H20223873 | 2022/11/22 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 杭州中美华东制药有限公司 | 杭州中美华东制药有限公司 | 国药准字H20227137 | 2022/10/21 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 通化东宝药业股份有限公司 | 通化东宝药业股份有限公司 | 国药准字H20213790 | 2021/10/19 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| 广东东阳光药业有限公司 | 广东东阳光药业有限公司 | 国药准字H20203440 | 2020/08/17 | 每片含磷酸西格列汀50mg（以西格列汀计）和盐酸二甲双胍850mg | 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 |
| MSD Pharma (Singapore) Pte.Ltd | Patheon Puerto Rico, Inc. (Manati) | H20140775 | 2012/07/23 | 磷酸西格列汀50mg（以游离碱计）和盐酸二甲双胍850mg | Imported originator drug (进口原研药品) | CDE |
| 北京元延医药科技股份有限公司 | 青岛黄海制药有限责任公司 | 国药准字H20265990 | 2026/09/15 | 每片含磷酸西格列汀50mg （以西格列汀计）和盐酸二甲双胍850mg | 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 |
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: 25 distinct approval numbers and 25 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京双鹭药业股份有限公司 | 国药准字H20263692 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010100148 | NHSA |
| 江苏康缘药业股份有限公司 | 国药准字H20253074 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010101463 | NHSA |
| MSD Merck Sharp & Dohme AG | 国药准字HJ20140775 | 磷酸西格列汀50mg(以游离碱计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010104495 | NHSA |
| 惠升生物制药股份有限公司 | 国药准字H20243802 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010182963 | NHSA |
| MSD Merck Sharp & Dohme AG | 国药准字HJ20140775 | 磷酸西格列汀50mg(以游离碱计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010204495 | NHSA |
| 惠升生物制药股份有限公司 | 国药准字H20243802 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010282963 | NHSA |
| 惠升生物制药股份有限公司 | 国药准字H20243802 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010382963 | NHSA |
| 石家庄市华新药业有限责任公司 | 国药准字H20264003 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010102753 | NHSA |
| 湖北午时医药研究院有限公司 | 国药准字H20263985 | 每片含磷酸西格列汀50mg(以西 格列汀计)和盐酸二甲双胍 850mg | Category B (乙) | XA10BDX223A001010184568 | NHSA |
| 甘李药业山东有限公司 | 国药准字H20263765 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010185033 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010185553 | NHSA |
| 甘李药业山东有限公司 | 国药准字H20263765 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010285033 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001020185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001030185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001040185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001050185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001060185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001070185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001080185553 | NHSA |
| 新石阳光药业(河北)有限公司 | 国药准字H20264418 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001090185553 | NHSA |
| 吉林长白山药业集团股份有限公司 | 国药准字H20244780 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010103364 | NHSA |
| 通化东宝药业股份有限公司 | 国药准字H20213790 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010103546 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20227137 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010104520 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20243712 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010104565 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20223873 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010104647 | NHSA |
| 浙江英格莱制药有限公司 | 国药准字H20249536 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010104749 | NHSA |
| 南昌立健药业有限公司 | 国药准字H20255970 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 850mg | Category B (乙) | XA10BDX223A001010105405 | NHSA |
| 齐鲁制药(海南)有限公司 | 国药准字H20233804 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010105847 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20243710 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010106632 | NHSA |
| 宜昌东阳光长江药业股份有限公司 | 国药准字H20203440 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010106988 | NHSA |
| 深圳翰宇药业股份有限公司 | 国药准字H20233025 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010179260 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd | H20140775 | 磷酸西格列汀50mg(以游离碱计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010179533 | NHSA |
| 浙江永太药业有限公司 | 国药准字H20253199 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍850mg(以C₄H₁₁N₅•HCl计) | Category B (乙) | XA10BDX223A001010181012 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010183521 | NHSA |
| 浙江九洲生物医药有限公司 | 国药准字H20243400 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010184212 | NHSA |
| 浙江易泽达医药科技有限公司 | 国药准字H20244159 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010184227 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010184415 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20227137 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010204520 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20243712 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010204565 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20223873 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010204647 | NHSA |
| 齐鲁制药(海南)有限公司 | 国药准字H20233804 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010205847 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20243710 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010206632 | NHSA |
| 宜昌东阳光长江药业股份有限公司 | 国药准字H20203440 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010206988 | NHSA |
| 深圳翰宇药业股份有限公司 | 国药准字H20233025 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010279260 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd | H20140775 | 磷酸西格列汀50mg(以游离碱计)和盐酸二甲双胍850mg | Category B (乙) | XA10BDX223A001010279533 | NHSA |
| 浙江永太药业有限公司 | 国药准字H20253199 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍850mg(以C₄H₁₁N₅•HCl计) | Category B (乙) | XA10BDX223A001010281012 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010283521 | NHSA |
| 浙江九洲生物医药有限公司 | 国药准字H20243400 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010284212 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010284415 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20223873 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010304647 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20243710 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010306632 | NHSA |
| 深圳翰宇药业股份有限公司 | 国药准字H20233025 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010379260 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010383521 | NHSA |
| 浙江九洲生物医药有限公司 | 国药准字H20243400 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010384212 | NHSA |
| 浙江易泽达医药科技有限公司 | 国药准字H20244159 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010384227 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010384415 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20223873 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010404647 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20243710 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010406632 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010483521 | NHSA |
| 浙江易泽达医药科技有限公司 | 国药准字H20244159 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010484227 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010484415 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20243710 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010506632 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010583521 | NHSA |
| 浙江易泽达医药科技有限公司 | 国药准字H20244159 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010584227 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010584415 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20243710 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010606632 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010683521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010684415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010783521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010784415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010883521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010884415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001010983521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001010984415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011083521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011084415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011183521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011184415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011283521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011284415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011383521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011384415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011483521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011484415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011583521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011584415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011683521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011684415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011783521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011784415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011883521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011884415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001011983521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001011984415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012083521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012084415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012183521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012184415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012283521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012284415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012383521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012384415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012483521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012484415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012583521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012584415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012683521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012684415 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20244899 | 每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍 | Category B (乙) | XA10BDX223A001012783521 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012784415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012884415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001012984415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013084415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013184415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013284415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013384415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013484415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013584415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013684415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013784415 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20243568 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX223A001013884415 | 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: 5 filings and 5 distinct first applicants.
Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 多多药业有限公司 | CYHS2503626 | Generic | 2025/10/11 | Not stated by source | CDE |
| 重庆圣华曦药业股份有限公司 | CYHS2201824 | Generic | 2022/10/25 | Not stated by source | CDE |
| 山东普瑞曼药业有限公司 | CYHS2601859 | Generic | 2026/08/03 | Not stated by source | CDE |
| 江西杏林白马药业股份有限公司 | CYHS2601246 | Generic | 2026/06/02 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2501932 | Generic | 2025/05/30 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 0 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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.
-
2026/10/23No longer listed under review
MSD Merck Sharp & Dohme AG;MSD International GmbH (Singapore Branch)
JYHB2600395
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/07/17
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/23No longer listed under review
MSD Merck Sharp & Dohme AG;MSD International GmbH (Singapore Branch)
JYHB2600394
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/07/17
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/21Supplement delivery
默沙东研发（中国）有限公司
JYHB2600395
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 167 ↗ -
2026/10/21Supplement delivery
默沙东研发（中国）有限公司
JYHB2600394
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 166 ↗
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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