Monthly
US$200
Billed every month
Bromhexine Hydrochloride Injection(盐酸溴己新注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 application
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 filings8View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers27View records ↓
API companies with A status19View records ↓
Chemical-drug catalogue
Loaded records: 29 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 26 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 |
|---|---|---|---|---|---|---|
| 多多药业有限公司 | 多多药业有限公司 | 国药准字H20265904 | 2026/09/08 | 2ml:4mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 福安药业集团宁波天衡制药有限公司 | 福安药业集团宁波天衡制药有限公司 | 国药准字H20265301 | 2026/07/21 | 2ml：4mg | 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 |
| 中玉制药（海口）有限公司 | 中玉制药（海口）有限公司 | 国药准字H20264521 | 2026/05/27 | 2ml:4mg | 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 |
| 西安达莫制药有限公司 | 陕西博森生物制药股份集团有限公司 | 国药准字H20264263 | 2026/05/07 | 2ml:4mg | 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 |
| 漯河市汇创医药有限公司 | 裕松源药业有限公司 | 国药准字H20263902 | 2026/05/06 | 2ml:4mg | 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 |
| 以岭万洲国际制药有限公司 | 山东京卫制药有限公司 | 国药准字H20264056 | 2026/04/21 | 2ml：4mg | 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 |
| 白云山东泰商丘药业有限公司 | 上海现代哈森(商丘)药业有限公司 | 国药准字H20263734 | 2026/03/25 | 2ml：4mg | 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 |
| 河北汇德旭盛医药科技有限公司 | 河北仁合益康药业有限公司 | 国药准字H20263026 | 2026/01/05 | 2ml：4mg | 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 |
| 陕西博森生物制药股份集团有限公司 | 陕西博森生物制药股份集团有限公司 | 国药准字H20256398 | 2025/12/22 | 2ml：4mg | 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 |
| 云南药科院生物医药股份有限公司 | 楚雄和创药业有限责任公司 | 国药准字H20255923 | 2025/11/12 | 2ml：4mg | 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 |
| 海南全星制药有限公司 | 海南全星制药有限公司 | 国药准字H20255538 | 2025/09/16 | 2ml：4mg | 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H20255075 | 2025/07/30 | 2ml:4mg | 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 |
| 峨眉山通惠制药有限公司 | 峨眉山通惠制药有限公司 | 国药准字H20255022 | 2025/07/29 | 2ml:4mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 安徽新世纪药业有限公司 | 平光制药股份有限公司 | 国药准字H20254535 | 2025/06/10 | 2ml:4mg | 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 |
| 山东圣鲁制药有限公司 | 山东圣鲁制药有限公司 | 国药准字H20057396 | 2024/10/16 | 2ml:4mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 湖北津药药业股份有限公司 | 湖北津药药业股份有限公司 | 国药准字H20244991 | 2024/09/26 | 2ml:4mg | 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 |
| 黑龙江珍宝岛药业股份有限公司 | 黑龙江珍宝岛药业股份有限公司 | 国药准字H20244392 | 2024/07/09 | 2ml:4mg | 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 |
| 海南葫芦娃药业集团股份有限公司 | 海南葫芦娃药业集团股份有限公司 | 国药准字H20243551 | 2024/04/24 | 2ml:4mg | 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 |
| 合肥国药诺和药业有限公司 | 国药集团国瑞药业有限公司 | 国药准字H20234640 | 2023/12/13 | 2ml:4mg | 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 |
| 吉林四长制药有限公司 | 吉林四长制药有限公司 | 国药准字H20234075 | 2023/08/29 | 2ml：4mg | 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 |
| 江苏正大清江制药有限公司 | 江苏正大清江制药有限公司 | 国药准字H20233628 | 2023/05/29 | 2ml：4mg | 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 |
| 万邦德制药集团有限公司 | 万邦德制药集团有限公司 | 国药准字H20223868 | 2022/11/22 | 2ml：4mg | 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 |
| 北京市新里程医药科技有限公司 | 成都市海通药业有限公司 | 国药准字H20223720 | 2022/10/11 | 2ml:4mg | 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 |
| 上海旭东海普药业有限公司 | 上海旭东海普药业有限公司 | 国药准字H31022703 | 2021/09/18 | 2ml：4mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 广州一品红制药有限公司 | 河北凯威制药有限责任公司 | 国药准字H20213726 | 2021/09/13 | 2ml:4mg | 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 |
| 江西亿友药业有限公司 | 江西银涛药业有限公司 | 国药准字Ｈ20213658 | 2021/08/25 | 2ml：4mg | 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 |
| 河北仁合益康药业有限公司 | 河北仁合益康药业有限公司 | 国药准字H20183123 | 2021/07/30 | 2ml：4mg | 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H20213214 | 2021/03/23 | 2ml:4mg | 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 |
| 成都欣捷高新技术开发股份有限公司 | 四川美大康佳乐药业有限公司 | 国药准字H20213154 | 2021/03/02 | 2ml:4mg | 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: 27 distinct approval numbers and 27 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 华润双鹤药业股份有限公司 | 国药准字H11022093 | 2ml:4mg | Category B (乙) | XR05CBX169B002010100144 | NHSA |
| 北京双鹭药业股份有限公司 | 国药准字H20256018 | 2ml:4mg | Category B (乙) | XR05CBX169B002010100148 | NHSA |
| 上海旭东海普药业有限公司 | 国药准字H31022703 | 2ml:4mg | Category B (乙) | XR05CBX169B002010100808 | NHSA |
| 江苏正大清江制药有限公司 | 国药准字H20233628 | 2ml:4mg | Category B (乙) | XR05CBX169B002010101522 | NHSA |
| 湖北津药药业股份有限公司 | 国药准字H20244991 | 2ml:4mg | Category B (乙) | XR05CBX169B002010101866 | NHSA |
| 再维药业(海南)有限公司 | 国药准字H20223720 | 2ml:4mg | Category B (乙) | XR05CBX169B002010102068 | NHSA |
| 峨眉山通惠制药有限公司 | 国药准字H20255022 | 2ml:4mg | Category B (乙) | XR05CBX169B002010102092 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20213154 | 2ml:4mg | Category B (乙) | XR05CBX169B002010102189 | NHSA |
| 石家庄四药有限公司 | 国药准字H20213214 | 2ml:4mg | Category B (乙) | XR05CBX169B002010102763 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20213726 | 2ml:4mg | Category B (乙) | XR05CBX169B002010102829 | NHSA |
| 上海现代哈森(商丘)药业有限公司 | 国药准字H20263734 | 2ml:4mg | Category B (乙) | XR05CBX169B002010103081 | NHSA |
| 吉林四长制药有限公司 | 国药准字H20234075 | 2ml:4mg | Category B (乙) | XR05CBX169B002010103282 | NHSA |
| 黑龙江珍宝岛药业股份有限公司 | 国药准字H20244392 | 2ml:4mg | Category B (乙) | XR05CBX169B002010103783 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20255075 | 2ml:4mg | Category B (乙) | XR05CBX169B002010104127 | NHSA |
| 山东圣鲁制药有限公司 | 国药准字H20057396 | 2ml:4mg | Category B (乙) | XR05CBX169B002010104207 | NHSA |
| 安徽新世纪药业有限公司 | 国药准字H20254535 | 2ml:4mg | Category B (乙) | XR05CBX169B002010104360 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H20265301 | 2ml:4mg | Category B (乙) | XR05CBX169B002010104561 | NHSA |
| 万邦德制药集团有限公司 | 国药准字H20223868 | 2ml:4mg | Category B (乙) | XR05CBX169B002010104723 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20213658 | 2ml:4mg | Category B (乙) | XR05CBX169B002010105381 | NHSA |
| 海南全星制药有限公司 | 国药准字H20255538 | 2ml:4mg | Category B (乙) | XR05CBX169B002010105765 | NHSA |
| 海南葫芦娃药业集团股份有限公司 | 国药准字H20243551 | 2ml:4mg | Category B (乙) | XR05CBX169B002010105789 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20183123 | 2ml:4mg | Category B (乙) | XR05CBX169B002010110349 | NHSA |
| 中玉制药(海口)有限公司 | 国药准字H20264521 | 2ml:4mg | Category B (乙) | XR05CBX169B002010183237 | NHSA |
| 西安达莫制药有限公司 | 国药准字H20264263 | 2ml:4mg | Category B (乙) | XR05CBX169B002010183239 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20234640 | 2ml:4mg | Category B (乙) | XR05CBX169B002010183719 | NHSA |
| 云南药科院生物医药股份有限公司 | 国药准字H20255923 | 2ml:4mg | Category B (乙) | XR05CBX169B002010184547 | NHSA |
| 河北汇德旭盛医药科技有限公司 | 国药准字H20263026 | 2ml:4mg | Category B (乙) | XR05CBX169B002010184987 | NHSA |
| 华润双鹤药业股份有限公司 | 国药准字H11022093 | 2ml:4mg | Category B (乙) | XR05CBX169B002010200144 | NHSA |
| 北京双鹭药业股份有限公司 | 国药准字H20256018 | 2ml:4mg | Category B (乙) | XR05CBX169B002010200148 | NHSA |
| 江苏正大清江制药有限公司 | 国药准字H20233628 | 2ml:4mg | Category B (乙) | XR05CBX169B002010201522 | NHSA |
| 湖北津药药业股份有限公司 | 国药准字H20244991 | 2ml:4mg | Category B (乙) | XR05CBX169B002010201866 | NHSA |
| 再维药业(海南)有限公司 | 国药准字H20223720 | 2ml:4mg | Category B (乙) | XR05CBX169B002010202068 | NHSA |
| 峨眉山通惠制药有限公司 | 国药准字H20255022 | 2ml:4mg | Category B (乙) | XR05CBX169B002010202092 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20213154 | 2ml:4mg | Category B (乙) | XR05CBX169B002010202189 | NHSA |
| 石家庄四药有限公司 | 国药准字H20213214 | 2ml:4mg | Category B (乙) | XR05CBX169B002010202763 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20213726 | 2ml:4mg | Category B (乙) | XR05CBX169B002010202829 | NHSA |
| 吉林四长制药有限公司 | 国药准字H20234075 | 2ml:4mg | Category B (乙) | XR05CBX169B002010203282 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20255075 | 2ml:4mg | Category B (乙) | XR05CBX169B002010204127 | NHSA |
| 山东圣鲁制药有限公司 | 国药准字H20057396 | 2ml:4mg | Category B (乙) | XR05CBX169B002010204207 | NHSA |
| 安徽新世纪药业有限公司 | 国药准字H20254535 | 2ml:4mg | Category B (乙) | XR05CBX169B002010204360 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H20265301 | 2ml:4mg | Category B (乙) | XR05CBX169B002010204561 | NHSA |
| 万邦德制药集团有限公司 | 国药准字H20223868 | 2ml:4mg | Category B (乙) | XR05CBX169B002010204723 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20213658 | 2ml:4mg | Category B (乙) | XR05CBX169B002010205381 | NHSA |
| 海南全星制药有限公司 | 国药准字H20255538 | 2ml:4mg | Category B (乙) | XR05CBX169B002010205765 | NHSA |
| 海南葫芦娃药业集团股份有限公司 | 国药准字H20243551 | 2ml:4mg | Category B (乙) | XR05CBX169B002010205789 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20183123 | 2ml:4mg | Category B (乙) | XR05CBX169B002010210349 | NHSA |
| 西安达莫制药有限公司 | 国药准字H20264263 | 2ml:4mg | Category B (乙) | XR05CBX169B002010283239 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20234640 | 2ml:4mg | Category B (乙) | XR05CBX169B002010283719 | NHSA |
| 云南药科院生物医药股份有限公司 | 国药准字H20255923 | 2ml:4mg | Category B (乙) | XR05CBX169B002010284547 | NHSA |
| 河北汇德旭盛医药科技有限公司 | 国药准字H20263026 | 2ml:4mg | Category B (乙) | XR05CBX169B002010284987 | NHSA |
| 北京双鹭药业股份有限公司 | 国药准字H20256018 | 2ml:4mg | Category B (乙) | XR05CBX169B002010300148 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20213154 | 2ml:4mg | Category B (乙) | XR05CBX169B002010302189 | NHSA |
| 石家庄四药有限公司 | 国药准字H20213214 | 2ml:4mg | Category B (乙) | XR05CBX169B002010302763 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20213658 | 2ml:4mg | Category B (乙) | XR05CBX169B002010305381 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20234640 | 2ml:4mg | Category B (乙) | XR05CBX169B002010383719 | NHSA |
| 河北汇德旭盛医药科技有限公司 | 国药准字H20263026 | 2ml:4mg | Category B (乙) | XR05CBX169B002010384987 | NHSA |
| 上海旭东海普药业有限公司 | 国药准字H31022703 | 2ml:4mg | Category B (乙) | XR05CBX169B002020100808 | NHSA |
| 中玉制药(海口)有限公司 | 国药准字H20264521 | 2ml:4mg | Category B (乙) | XR05CBX169B002020183237 | 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: 8 filings and 8 distinct first applicants.
Generic 6 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东齐都药业有限公司 | CYHS2602137 | Generic | 2026/08/27 | Not stated by source | CDE |
| 湖北津药药业股份有限公司 | CYHB2601083 | Supplement | 2026/06/10 | Not stated by source | CDE |
| 湖北美林药业有限公司 | CYHB2600858 | Supplement | 2026/05/01 | Not stated by source | CDE |
| 河南普瑞药业有限公司 | CYHS2600830 | Generic | 2026/04/10 | Not stated by source | CDE |
| 成都华宇制药有限公司 | CYHS2502423 | Generic | 2025/07/08 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2501654 | Generic | 2025/05/08 | Not stated by source | CDE |
| 重庆药友制药有限责任公司 | CYHS2500847 | Generic | 2025/02/26 | Not stated by source | CDE |
| 湖北民康药业集团有限公司;湖北美林药业有限公司 | CYHS2500834 | Generic | 2025/02/25 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 19 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 盐酸溴己新 | 湖北美林药业有限公司 | Y20240001175 | A | Exact ingredient | 2026/08/13 | CDE |
| 盐酸溴己新 | 药康众拓（江苏）医药科技有限公司 | Y20240001095 | I | Exact ingredient | 2026/01/08 | CDE |
| 盐酸溴己新 | 湖北午时药业股份有限公司 | Y20230000895 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸溴己新 | 白云山东泰商丘药业有限公司 | Y20230000613 | A | Exact ingredient | 2026/01/23 | CDE |
| 盐酸溴己新 | 山东齐都药业有限公司 | Y20230000542 | A | Exact ingredient | 2025/12/03 | CDE |
| 盐酸溴己新 | 武邑慈航药业有限公司 | Y20220000824 | A | Exact ingredient | 2025/09/24 | CDE |
| 盐酸溴己新 | 成都新恒创药业有限公司 | Y20220000708 | A | Exact ingredient | 2026/01/22 | CDE |
| 盐酸溴己新 | VEN PETROCHEM & PHARMA (INDIA) PVT LTD. | Y20210000882 | A | Exact ingredient | 2024/07/26 | CDE |
| 盐酸溴己新 | 江西博雅欣和制药有限公司 | Y20200000365 | A | Exact ingredient | 2026/05/06 | CDE |
| 盐酸溴己新 | 上海旭东海普南通药业有限公司 | Y20190021429 | A | Exact ingredient | 2026/03/21 | CDE |
| 盐酸溴己新 | 广州一品红制药有限公司 | Y20190000846 | A | Exact ingredient | 2026/07/31 | CDE |
| 盐酸溴己新 | 湖南尔康制药股份有限公司 | Y20190008448 | A | Exact ingredient | 2025/02/08 | CDE |
| 盐酸溴己新 | 江西亿友药业有限公司 | Y20190008344 | A | Exact ingredient | 2024/06/04 | CDE |
| 盐酸溴己新 | 太仓制药厂 | Y20190007187 | A | Exact ingredient | 2024/03/29 | CDE |
| 盐酸溴己新 | 浙江乐普药业股份有限公司 | Y20190004465 | A | Exact ingredient | 2025/05/01 | CDE |
| 盐酸溴己新 | 华润双鹤药业股份有限公司 | Y20190003977 | A | Exact ingredient | — | CDE |
| 盐酸溴己新 | 万邦德制药集团有限公司 | Y20190003549 | A | Exact ingredient | 2025/06/19 | CDE |
| 盐酸溴己新 | 成都新恒创药业有限公司 | Y20180001038 | A | Exact ingredient | 2026/01/09 | CDE |
| 盐酸溴己新 | 江苏润安制药有限公司 | Y20170001511 | A | Exact ingredient | 2026/09/12 | CDE |
| 盐酸溴己新 | 河北创健药业有限公司 | Y20170000639 | A | Exact ingredient | 2024/02/23 | CDE |
| 盐酸溴己新 | BIDACHEM SPA | Y20170000561 | I | Exact ingredient | — | CDE |
| 盐酸溴己新 | 河北国龙制药有限公司 | Y20170000261 | A | Exact ingredient | 2023/07/02 | 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.
-
2026/08/27Accepted
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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