Monthly
US$200
Billed every month
Moxifloxacin Hydrochloride Tablets(盐酸莫西沙星片)
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 holders29View records ↓
Under-review filings11View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers32View records ↓
API companies with A status48View records ↓
Chemical-drug catalogue
Loaded records: 29 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 27 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 |
|---|---|---|---|---|---|---|
| 新天地药业股份有限公司 | 许昌未来制药有限责任公司 | 国药准字H20264303 | 2026/05/12 | 0.4g（按C21H24FN3O4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 |
| 重庆世森医药科技有限公司 | 兰西哈三联制药有限公司 | 国药准字H20264233 | 2026/05/07 | 0.4g（按C21H24FN3O4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 |
| 辰欣药业股份有限公司 | 辰欣药业股份有限公司 | 国药准字H20263789 | 2026/03/31 | 0.4g（按C21H24FN3O4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 |
| 哈尔滨珍宝制药有限公司 | 哈尔滨珍宝制药有限公司 | 国药准字H20256080 | 2025/11/25 | 0.4g（按C21H24FN3O4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 |
| 四川迪菲特药业有限公司 | 吉林四环制药有限公司 | 国药准字H20255081 | 2025/07/30 | 0.4g（按C21H24FN3O4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 |
| 珠海润都制药股份有限公司 | 珠海润都制药股份有限公司 | 国药准字H20254689 | 2025/06/30 | 0.4g（按C21H24FN3O4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 |
| 山西德元堂药业有限公司 | 山西德元堂药业有限公司 | 国药准字H20253145 | 2025/01/14 | 0.4g（按C21H24FN3O4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 |
| 河北天成药业股份有限公司 | 河北天成药业股份有限公司 | 国药准字H20253104 | 2025/01/08 | 0.4g（按C21H24FN3O4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 |
| 山东鲁抗医药股份有限公司 | 山东鲁抗医药股份有限公司 | 国药准字H20244634 | 2024/08/05 | 0.4g（按C21H24FN3O4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 |
| 江苏联环药业股份有限公司 | 江苏联环药业股份有限公司 | 国药准字H20244079 | 2024/06/18 | 0.4g（按C21H24FN3O4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 |
| 浙江永太药业有限公司 | 浙江永太药业有限公司 | 国药准字H20244077 | 2024/06/18 | 0.4g（按C21H24FN3O4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 |
| 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H20233577 | 2023/05/19 | 0.4g（按C21H24FN3O4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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20223006 | 2022/01/07 | 0.4g（按C21H24FN3O4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 |
| 桂林南药股份有限公司 | 桂林南药股份有限公司 | 国药准字H20213851 | 2021/11/03 | 0.4g（按C21H24FN3O4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H20213609 | 2021/07/28 | 0.4g（按C21H24FN3O4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 |
| 扬子江药业集团江苏紫龙药业有限公司 | 扬子江药业集团江苏紫龙药业有限公司 | 国药准字H20213553 | 2021/06/29 | 0.4g（按C21H24FN3O4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 |
| 湖南迪诺制药股份有限公司 | 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 2021/06/16 | 0.4g（以C21H24FN3O4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 |
| HEXAL AG | S.C. Sandoz S.R.L. | 国药准字HJ20210032 | 2021/05/19 | 0.4g（按C21H24FN3O4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 |
| 江苏天一时制药有限公司 | 江苏天一时制药有限公司 | 国药准字H20213323 | 2021/04/30 | 0.4g（按C21H24FN3O4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 |
| 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H20203516 | 2020/10/15 | 0.4g（按C21H24FN3O4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 |
| 湖南天济草堂制药股份有限公司 | 湖南天济草堂制药股份有限公司 | 国药准字H20203433 | 2020/08/17 | 0.4g（以C21H24FN3O4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 |
| 深圳信立泰药业股份有限公司 | 深圳信立泰药业股份有限公司 | 国药准字H20203062 | 2020/02/25 | 0.4g（以C21H24FN3O4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 |
| 南京圣和药业股份有限公司 | 南京圣和药业股份有限公司 | 国药准字H20193432 | 2019/12/30 | 0.4g（按C21H24FN3O4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 |
| — | 重庆华邦制药有限公司 | 国药准字H20193406 | 2019/12/26 | 0.4g（按C21H24FN3O4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 |
| — | 南京优科制药有限公司 | 国药准字H20193387 | 2019/12/18 | 0.4g（按C21H24FN3O4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 |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20183096 | 2019/12/17 | 0.4g(按C21H24FN3O4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 |
| 四川国为制药有限公司 | 四川国为制药有限公司 | 国药准字H20183530 | 2018/12/25 | 0.4g（按C21H24FN3O4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H20183246 | 2018/07/06 | 0.4g（以莫西沙星计） | 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 |
| Bayer Vital GmbH | Bayer Pharma AG | H20140721;H20140722;H20140723 | 2002/08/30 | 0.4g | 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: 32 distinct approval numbers and 29 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Bayer Vital GmbH | 国药准字J20150015 | 0.4g | Category B (乙) | XJ01MAM122A001010100002 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20183096 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010100177 | NHSA |
| 深圳信立泰药业股份有限公司 | 国药准字H20203062 | 0.4g(以C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010100553 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010100601 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20193406 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010101003 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010101467 | NHSA |
| 南京圣和药业股份有限公司 | 国药准字H20193432 | 0.4g(以C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010101583 | NHSA |
| 四川迪菲特药业有限公司 | 国药准字H20255081 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010102064 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203516 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010102180 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010102662 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223006 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010102763 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010102877 | NHSA |
| 哈尔滨珍宝制药有限公司 | 国药准字H20256080 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010103783 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010104127 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20213609 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010104152 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20233577 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010104565 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20213367 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010104641 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010104914 | NHSA |
| 桂林南药股份有限公司 | 国药准字H20213851 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010105206 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20183246 | 0.4g(以莫西沙星计) | Category B (乙) | XJ01MAM122A001010106988 | NHSA |
| 湖南天济草堂制药股份有限公司 | 国药准字H20203433 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010109604 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140721 | 0.4g | Category B (乙) | XJ01MAM122A001010178271 | NHSA |
| 南京优科制药有限公司 | 国药准字H20193387 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010180542 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010180937 | NHSA |
| 浙江永太药业有限公司 | 国药准字H20244077 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010181012 | NHSA |
| 扬子江药业集团江苏紫龙药业有限公司 | 国药准字H20213553 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010182147 | NHSA |
| 新天地药业股份有限公司 | 国药准字H20264303 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010182462 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20244634 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010183198 | NHSA |
| 重庆世森医药科技有限公司 | 国药准字H20264233 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010183546 | NHSA |
| 江苏天一时制药有限公司 | 国药准字H20213323 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010183586 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20183096 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010200177 | NHSA |
| 深圳信立泰药业股份有限公司 | 国药准字H20203062 | 0.4g(以C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010200553 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010200601 | NHSA |
| 重庆华邦制药有限公司 | 国药准字H20193406 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010201003 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010201467 | NHSA |
| 南京圣和药业股份有限公司 | 国药准字H20193432 | 0.4g(以C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010201583 | NHSA |
| 四川迪菲特药业有限公司 | 国药准字H20255081 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010202064 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203516 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010202180 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010202662 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223006 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010202763 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010202877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010204127 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20213609 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010204152 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20233577 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010204565 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20213367 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010204641 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010204914 | NHSA |
| 桂林南药股份有限公司 | 国药准字H20213851 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010205206 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20183246 | 0.4g(以莫西沙星计) | Category B (乙) | XJ01MAM122A001010206988 | NHSA |
| 湖南天济草堂制药股份有限公司 | 国药准字H20203433 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010209604 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140722 | 0.4g | Category B (乙) | XJ01MAM122A001010278271 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010280937 | NHSA |
| 浙江永太药业有限公司 | 国药准字H20244077 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010281012 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20244634 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010283198 | NHSA |
| 重庆世森医药科技有限公司 | 国药准字H20264233 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010283546 | NHSA |
| 江苏天一时制药有限公司 | 国药准字H20213323 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010283586 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20183096 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010300177 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010300601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010301467 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010302662 | NHSA |
| 石家庄四药有限公司 | 国药准字H20223006 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010302763 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010302877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010304127 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20233577 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010304565 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20213367 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010304641 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010304914 | NHSA |
| 桂林南药股份有限公司 | 国药准字H20213851 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010305206 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140722 | 0.4g | Category B (乙) | XJ01MAM122A001010378271 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010380937 | NHSA |
| 浙江永太药业有限公司 | 国药准字H20244077 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010381012 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20183096 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010400177 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010400601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010401467 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010402662 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010402877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010404127 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20233577 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010404565 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20213367 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010404641 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010404914 | NHSA |
| 桂林南药股份有限公司 | 国药准字H20213851 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010405206 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20183096 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010500177 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010500601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010501467 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010502662 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010502877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010504127 | NHSA |
| 宁波美诺华天康药业有限公司 | 国药准字H20233577 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010504565 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20213367 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010504641 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010504914 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140723 | 0.4g | Category B (乙) | XJ01MAM122A001010578271 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20183096 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010600177 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010600601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010601467 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010602662 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010602877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010604127 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20213367 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010604641 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010604914 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010700601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010701467 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010702662 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010702877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010704127 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010704914 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010800601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010801467 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20253104 | 0.4g(按 C21H24FN3O4 计) | Category B (乙) | XJ01MAM122A001010802662 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010802877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010804127 | NHSA |
| 湖南迪诺制药股份有限公司 | 国药准字H20213500 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001010804914 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010900601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010901467 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20253145 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010902877 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001010904127 | NHSA |
| 珠海润都制药股份有限公司 | 国药准字H20254689 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011000601 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011001467 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011004127 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011101467 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011104127 | NHSA |
| 江苏联环药业股份有限公司 | 国药准字H20244079 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011201467 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011204127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011304127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011404127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20263789 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001011504127 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20183246 | 0.4g(以莫西沙星计) | Category B (乙) | XJ01MAM122A001020106988 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020180937 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20244634 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001020183198 | NHSA |
| 江苏天一时制药有限公司 | 国药准字H20213323 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020183586 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020280937 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20244634 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001020283198 | NHSA |
| 江苏天一时制药有限公司 | 国药准字H20213323 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020283586 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020380937 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20244634 | 0.4g(按C₂₁H₂₄FN₃O₄计) | Category B (乙) | XJ01MAM122A001020383198 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020480937 | NHSA |
| 四川国为制药有限公司 | 国药准字H20183530 | 0.4g(按C21H24FN3O4计) | Category B (乙) | XJ01MAM122A001020580937 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20183246 | 0.4g(以莫西沙星计) | Category B (乙) | XJ01MAM122A001030106988 | NHSA |
| 东莞市阳之康医药有限责任公司 | 国药准字H20183246 | 0.4g(以莫西沙星计) | Category B (乙) | XJ01MAM122A001040106988 | 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: 11 filings and 8 distinct first applicants.
Supplement 5 · Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Bayer Vital GmbH;Bayer HealthCare Manufacturing S.r.l. | JYHB2600455 | Supplement | 2026/08/12 | Not stated by source | CDE |
| 四川国为制药有限公司 | CYHB2600779 | Supplement | 2026/04/18 | Not stated by source | CDE |
| 上海金不换兰考制药有限公司 | CYHS2600411 | Generic | 2026/02/09 | Not stated by source | CDE |
| 北大医药股份有限公司 | CYHS2600143 | Generic | 2026/01/12 | Not stated by source | CDE |
| 江西鸿烁制药有限责任公司 | CYHS2504102 | Generic | 2025/11/28 | Not stated by source | CDE |
| 郑州韩都药业集团有限公司 | CYHS2503969 | Generic | 2025/11/15 | Not stated by source | CDE |
| 吉林道君药业股份有限公司 | CYHS2503917 | Generic | 2025/11/11 | Not stated by source | CDE |
| Bayer Vital GmbH;Bayer HealthCare Manufacturing S.r.l.;- | JYHB2500581 | Supplement | 2025/10/31 | Not stated by source | CDE |
| Bayer Vital GmbH;Bayer HealthCare Manufacturing S.r.l. | JYHB2500580 | Supplement | 2025/10/31 | Not stated by source | CDE |
| Bayer Vital GmbH;Bayer HealthCare Manufacturing S.r.l. | JYHB2500579 | Supplement | 2025/10/31 | Not stated by source | CDE |
| 海南海力制药有限公司 | CYHS2501805 | Generic | 2025/05/17 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 48 companies with A status and 16 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 |
|---|---|---|---|---|---|---|
| 盐酸莫西沙星 | 江西善渊药业有限公司 | Y20260000402 | I | Exact ingredient | 2026/09/17 | CDE |
| 盐酸莫西沙星 | 江西祥太生命科学有限公司 | Y20240000879 | I | Exact ingredient | 2024/08/23 | CDE |
| 盐酸莫西沙星 | 兰西哈三联制药有限公司 | Y20230001071 | A | Exact ingredient | 2025/07/22 | CDE |
| 盐酸莫西沙星 | 浙江新和成股份有限公司 | Y20230000900 | A | Exact ingredient | 2026/03/31 | CDE |
| 盐酸莫西沙星 | 河北天成药业股份有限公司 | Y20220000887 | A | Exact ingredient | 2024/07/09 | CDE |
| 盐酸莫西沙星 | 河北凯威康领制药有限公司 | Y20220000860 | A | Exact ingredient | 2024/12/04 | CDE |
| 盐酸莫西沙星 | 山东鲁抗医药股份有限公司 | Y20220000493 | A | Exact ingredient | 2025/12/24 | CDE |
| 盐酸莫西沙星 | 西安万隆制药股份有限公司 | Y20220000473 | I | Exact ingredient | 2022/07/05 | CDE |
| 盐酸莫西沙星 | 宜昌东阳光制药有限公司 | Y20220000196 | A | Exact ingredient | 2025/09/06 | CDE |
| 盐酸莫西沙星 | 黑龙江珍宝岛药业股份有限公司鸡西分公司 | Y20220000100 | A | Exact ingredient | 2025/06/07 | CDE |
| 盐酸莫西沙星 | 常州红太阳药业有限公司 | Y20210001254 | A | Exact ingredient | 2024/04/28 | CDE |
| 盐酸莫西沙星 | 重庆市南岸区江桥路8号 | Y20210001098 | A | Exact ingredient | 2026/07/16 | CDE |
| 盐酸莫西沙星 | 新天地药业股份有限公司 | Y20210000980 | A | Exact ingredient | 2026/02/27 | CDE |
| 盐酸莫西沙星 | 安徽尖峰北卡药业有限公司 | Y20210000527 | A | Exact ingredient | 2025/12/23 | CDE |
| 盐酸莫西沙星 | 辽源市银鹰制药有限责任公司 | Y20210000273 | A | Exact ingredient | 2026/07/28 | CDE |
| 盐酸莫西沙星 | 浙江燎原药业有限公司 | Y20210000103 | A | Exact ingredient | 2023/05/05 | CDE |
| 盐酸莫西沙星 | 浙江医药股份有限公司新昌制药厂 | Y20200000494 | A | Exact ingredient | 2022/08/03 | CDE |
| 盐酸莫西沙星 | 四川国为制药有限公司 | Y20190009766 | A | Exact ingredient | 2026/09/08 | CDE |
| 盐酸莫西沙星 | 南京优科制药有限公司 | Y20190006998 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸莫西沙星 | 瑞阳制药股份有限公司 | Y20190000968 | A | Exact ingredient | 2026/06/18 | CDE |
| 盐酸莫西沙星 | 四川国为制药有限公司 | Y20190000446 | A | Exact ingredient | 2026/09/08 | CDE |
| 盐酸莫西沙星 | 北京福元医药股份有限公司 | Y20190000466 | A | Exact ingredient | 2025/09/24 | CDE |
| 盐酸莫西沙星 | 浙江新和成股份有限公司 | Y20190000343 | A | Exact ingredient | 2025/07/23 | CDE |
| 盐酸莫西沙星 | 武汉武药制药有限公司 | Y20190000161 | I | Exact ingredient | 2019/04/01 | CDE |
| 盐酸莫西沙星 | 湖南洞庭药业股份有限公司 | Y20180001456 | I | Exact ingredient | 2019/01/08 | CDE |
| 盐酸莫西沙星 | 浙江国邦药业有限公司 | Y20180001255 | A | Exact ingredient | 2025/11/27 | CDE |
| 盐酸莫西沙星 | 江苏天一时制药有限公司 | Y20180001088 | A | Exact ingredient | 2026/04/24 | CDE |
| 盐酸莫西沙星 | 江苏永达药业有限公司 | Y20180000618 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 桂林南药股份有限公司 | Y20170002212 | A | Exact ingredient | 2025/11/15 | CDE |
| 盐酸莫西沙星 | 四川新开元制药有限公司 | Y20170001688 | A | Exact ingredient | 2026/06/23 | CDE |
| 盐酸莫西沙星 | 浙江海正药业股份有限公司 | Y20170001678 | A | Exact ingredient | 2025/12/27 | CDE |
| 盐酸莫西沙星 | 南京圣和药业股份有限公司 | Y20170001585 | A | Exact ingredient | 2024/06/06 | CDE |
| 盐酸莫西沙星 | 湖南天济草堂制药有限公司 | Y20170001536 | A | Exact ingredient | 2022/10/20 | CDE |
| 盐酸莫西沙星 | MSN Pharmachem Private Limited | Y20170001468 | A | Exact ingredient | 2025/12/09 | CDE |
| 盐酸莫西沙星 | 北大医药股份有限公司 | Y20170001426 | A | Exact ingredient | 2024/08/27 | CDE |
| 盐酸莫西沙星 | Dr.Reddy's Laboratories Ltd. | Y20170001362 | A | Exact ingredient | 2023/04/02 | CDE |
| 盐酸莫西沙星 | 厦门恩成制药有限公司 | Y20170001344 | I | Exact ingredient | 2019/05/28 | CDE |
| 盐酸莫西沙星 | 山西振东泰盛制药有限公司 | Y20170001318 | A | Exact ingredient | 2026/09/18 | CDE |
| 盐酸莫西沙星 | 沈阳中海药业有限公司 | Y20170001311 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 重庆青阳药业有限公司 | Y20170001287 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 山西同达药业有限公司 | Y20170001220 | A | Exact ingredient | 2022/10/24 | CDE |
| 盐酸莫西沙星 | Hetero Drugs Limited | Y20170001086 | A | Exact ingredient | 2025/11/21 | CDE |
| 盐酸莫西沙星 | 湖南迪诺制药股份有限公司 | Y20170001062 | A | Exact ingredient | 2025/07/28 | CDE |
| 盐酸莫西沙星 | 四川协力制药股份有限公司 | Y20170001005 | A | Exact ingredient | 2024/02/08 | CDE |
| 盐酸莫西沙星 | 山东新华制药股份有限公司 | Y20170000961 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 昆明源瑞制药有限公司 | Y20170000940 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 陕西大生制药科技有限公司 | Y20170000927 | A | Exact ingredient | 2024/02/08 | CDE |
| 盐酸莫西沙星 | 河北国龙制药有限公司 | Y20170000871 | A | Exact ingredient | 2025/09/16 | CDE |
| 盐酸莫西沙星 | 深圳信立泰药业股份有限公司 | Y20170000820 | A | Exact ingredient | 2023/09/14 | CDE |
| 盐酸莫西沙星 | 大同长兴制药有限责任公司 | Y20170000811 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 江苏正大丰海制药有限公司 | Y20170000806 | A | Exact ingredient | 2025/03/20 | CDE |
| 盐酸莫西沙星 | 珠海润都制药股份有限公司 | Y20170000798 | A | Exact ingredient | 2025/07/19 | CDE |
| 盐酸莫西沙星 | 浙江新和成股份有限公司 | Y20170000789 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸莫西沙星 | 成都通德药业有限公司 | Y20170000786 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸莫西沙星 | 山东齐都药业有限公司 | Y20170000737 | A | Exact ingredient | 2024/01/12 | CDE |
| 盐酸莫西沙星 | 江苏云阳集团药业有限公司 | Y20170000704 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 宜昌东阳光长江药业股份有限公司 | Y20170000682 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸莫西沙星 | 辽宁本源制药有限公司 | Y20170000663 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 天方药业有限公司 | Y20170000640 | A | Exact ingredient | 2026/04/30 | CDE |
| 盐酸莫西沙星 | 重庆胜凯制药有限公司 | Y20170000595 | A | Exact ingredient | 2026/08/22 | CDE |
| 盐酸莫西沙星 | 江苏苏中药业集团股份有限公司 | Y20170000575 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 天津红日药业股份有限公司 | Y20170000298 | A | Exact ingredient | 2024/11/26 | CDE |
| 盐酸莫西沙星 | 四川青木制药有限公司 | Y20170000255 | A | Exact ingredient | 2026/03/03 | CDE |
| 盐酸莫西沙星 | 国药集团宜宾制药有限责任公司 | Y20170000071 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20170000034 | A | Exact ingredient | 2025/12/31 | CDE |
| 盐酸莫西沙星 | 陕西太白山制药有限责任公司 | Y20170000024 | A | Exact ingredient | 2022/10/21 | CDE |
| 盐酸莫西沙星 | 连云港润众制药有限公司 | Y20170000007 | A | Exact ingredient | 2024/04/19 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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