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Sign in to subscribeAs of 13 November 2026, for Bumetanide Injection, 13 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 39 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationNo longer listed under review: 4 applicationsNotification delivery: 1 application
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 2 of 2 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Injection. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| BUMEX | VALIDUS PHARMACEUTICALS LLC | NDA 018226 · Product no. 001 | INJECTABLE | INJECTION | DISCONTINUED | 1983/02/28 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| BUMEX | VALIDUS PHARMACEUTICALS LLC | NDA 018225 · Product no. 001, 002 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 1983/02/28 |
| BUMEX | VALIDUS PHARMACEUTICALS LLC | NDA 018225 · Product no. 003 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 1985/06/14 |
| ENBUMYST | CORSTASIS THERAPEUTICS INC | NDA 219500 · Product no. 001 | SPRAY | NASAL | HUMAN PRESCRIPTION DRUG | 2025/09/12 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Loaded records: 39 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 35 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 |
|---|---|---|---|---|---|---|
| Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized | Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20266280 | 2026/10/13 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20265932 | 2026/09/15 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20265931 | 2026/09/15 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized | Ji Ning Shen Zhou Pharmaceuticals Co., Ltd. romanized | 国药准字H20265596 | 2026/08/04 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Kai Yuan Pharma Co., Ltd. romanized | Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized | 国药准字H20265597 | 2026/08/04 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H20265458 | 2026/08/04 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H20265457 | 2026/08/04 | 2ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yunnan Hua Pai Pharmaceuticals Technology Co., Ltd. romanized | Chu Xiong He Chuang Pharma Co., Ltd. romanized | 国药准字H20265514 | 2026/08/04 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Henan Xin Tai Pharma Co., Ltd. romanized | Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H20057376 | 2026/07/30 | 2ml:0.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H20265213 | 2026/07/21 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H33020980 | 2026/06/26 | 2ml:0.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264734 | 2026/06/10 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20269129 | 2026/06/02 | 1ml∶0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20264515 | 2026/05/27 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20264514 | 2026/05/27 | 2ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20264479 | 2026/05/19 | 1ml : 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20264478 | 2026/05/19 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264440 | 2026/05/19 | 1ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20269095 | 2026/04/21 | 1ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263951 | 2026/04/14 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | 国药准字H20263885 | 2026/04/07 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | 国药准字H20263884 | 2026/04/07 | 2ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20269077 | 2026/03/27 | 1ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20263723 | 2026/03/25 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized | Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20263469 | 2026/02/25 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20263182 | 2026/01/20 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Te Rui Pharma Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20263065 | 2026/01/14 | 4ml : 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20263061 | 2026/01/14 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Te Rui Pharma Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20263066 | 2026/01/14 | 1ml : 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20263011 | 2026/01/05 | 1ml:0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20263012 | 2026/01/05 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | 国药准字H20256301 | 2025/12/16 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | 国药准字H20256300 | 2025/12/16 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Liu Huan Pharma Co., Ltd. romanized | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20256311 | 2025/12/16 | 4ml∶2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256235 | 2025/12/09 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | Jiangsu Yue Xing Pharma Co., Ltd. romanized | 国药准字H20256032 | 2025/11/25 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20256033 | 2025/11/25 | 4ml∶2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical (Hainan) Co., Ltd | Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20255275 | 2025/09/02 | 4ml: 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20255333 | 2025/09/02 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20255030 | 2025/07/29 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20254921 | 2025/07/22 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20254920 | 2025/07/22 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20254456 | 2025/06/03 | 2ml∶0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20254036 | 2025/04/30 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20253699 | 2025/03/25 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20253233 | 2025/01/24 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20249747 | 2024/12/17 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20249728 | 2024/12/10 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Giantech Hi-technology Development Co., Ltd. | E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20244549 | 2024/07/30 | 4ml:1mg | Not stated by source | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized | Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20057225 | 2024/04/15 | 2ml:1mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized | Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20247066 | 2024/04/15 | 1ml:0.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Ping Guang Pharmaceutical Co., Ltd. romanized | Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20264124 | 2026/04/21 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264735 | 2026/06/10 | 2ml:1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20266291 | 2026/10/20 | 4ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20264569 | 2026/05/27 | 4ml:1mg | Generic approved under the new chemical-drug registration classification | 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: 57 distinct approval numbers and 45 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Shi Yong Kang Pharma Co., Ltd. romanized | 国药准字H11020587 | 2ml:0.5mg | Category B | XC03CAB176B002010100137 | NHSA |
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20066846 | 2ml:0.5mg | Category B | XC03CAB176B002010100267 | NHSA |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H31021523 | 2ml:0.5mg | Category B | XC03CAB176B002010100673 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50021461 | 2ml:0.5mg | Category B | XC03CAB176B002010100978 | NHSA |
| Liaoning Yu Huang Pharma Co., Ltd. romanized | 国药准字H20083500 | 2ml:1mg | Category B | XC03CAB176B002010101247 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264734 | 4ml:2mg | Category B | XC03CAB176B002010101495 | NHSA |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H20057023 | 2ml:0.5mg | Category B | XC03CAB176B002010101866 | NHSA |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H42020894 | 2ml:0.5mg | Category B | XC03CAB176B002010101949 | NHSA |
| Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized | 国药准字H20263469 | 4ml:2mg | Category B | XC03CAB176B002010102065 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20253699 | 4ml:2mg | Category B | XC03CAB176B002010102087 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20253233 | 4ml:1mg | Category B | XC03CAB176B002010102181 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20263723 | 2ml:1mg | Category B | XC03CAB176B002010102763 | NHSA |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H20057376 | 2ml:0.5mg | Category B | XC03CAB176B002010103091 | NHSA |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256235 | 4ml:2mg | Category B | XC03CAB176B002010103205 | NHSA |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20249747 | 4ml: 2mg | Category B | XC03CAB176B002010103216 | NHSA |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H20265213 | 4ml:2mg | Category B | XC03CAB176B002010104083 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263951 | 4ml:1mg | Category B | XC03CAB176B002010104127 | NHSA |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H33020980 | 2ml:0.5mg | Category B | XC03CAB176B002010104757 | NHSA |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | 国药准字H35020460 | 2ml:0.5mg | Category B | XC03CAB176B002010104827 | NHSA |
| Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H45020076 | 2ml:0.5mg | Category B | XC03CAB176B002010105156 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H45020960 | 2ml:0.5mg | Category B | XC03CAB176B002010105206 | NHSA |
| Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 国药准字H20057248 | 2ml:0.5mg | Category B | XC03CAB176B002010105843 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20255275 | 4ml: 2mg | Category B | XC03CAB176B002010105847 | NHSA |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H20163098 | 2ml:0.5mg | Category B | XC03CAB176B002010107698 | NHSA |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20256033 | 4ml∶2mg | Category B | XC03CAB176B002010109910 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20255030 | 4ml:1mg | Category B | XC03CAB176B002010109920 | NHSA |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20264569 | 4ml:1mg | Category B | XC03CAB176B002010109921 | NHSA |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H20263065 | 4ml : 2mg | Category B | XC03CAB176B002010110121 | NHSA |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20264124 | 4ml:2mg | Category B | XC03CAB176B002010180610 | NHSA |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20263011 | 1ml:0.5mg | Category B | XC03CAB176B002010182234 | NHSA |
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264071 | 4ml : 2mg | Category B | XC03CAB176B002010183094 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20244549 | 4ml∶1mg | Category B | XC03CAB176B002010183325 | NHSA |
| Suzhou Lang Ke Bio Technology Co., Ltd. romanized | 国药准字H20263182 | 2ml:1mg | Category B | XC03CAB176B002010183485 | NHSA |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254036 | 4ml:2mg | Category B | XC03CAB176B002010183960 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249728 | 4ml:2mg | Category B | XC03CAB176B002010184135 | NHSA |
| Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263061 | 4ml : 1mg | Category B | XC03CAB176B002010184156 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20254921 | 2ml:1mg | Category B | XC03CAB176B002010184534 | NHSA |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H20256036 | 4ml:2mg | Category B | XC03CAB176B002010184779 | NHSA |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264478 | 4ml:2mg | Category B | XC03CAB176B002010184954 | NHSA |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255333 | 4ml:1mg | Category B | XC03CAB176B002010185074 | NHSA |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20264515 | 2ml:1mg | Category B | XC03CAB176B002010185467 | NHSA |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256300 | 2ml:1mg | Category B | XC03CAB176B002010185482 | NHSA |
| Beijing Liu Huan Pharma Co., Ltd. romanized | 国药准字H20256311 | 4ml:2mg | Category B | XC03CAB176B002010185484 | NHSA |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20264514 | 2ml:0.5mg | Category B | XC03CAB176B002010185560 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50021461 | 2ml:0.5mg | Category B | XC03CAB176B002010200978 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264734 | 4ml:2mg | Category B | XC03CAB176B002010201495 | NHSA |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H20057023 | 2ml:0.5mg | Category B | XC03CAB176B002010201866 | NHSA |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H42020894 | 2ml:0.5mg | Category B | XC03CAB176B002010201949 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20253699 | 4ml:2mg | Category B | XC03CAB176B002010202087 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20263723 | 2ml:1mg | Category B | XC03CAB176B002010202763 | NHSA |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H20057376 | 2ml:0.5mg | Category B | XC03CAB176B002010203091 | NHSA |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256235 | 4ml:2mg | Category B | XC03CAB176B002010203205 | NHSA |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20249747 | 4ml: 2mg | Category B | XC03CAB176B002010203216 | NHSA |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H20265213 | 4ml:2mg | Category B | XC03CAB176B002010204083 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263951 | 4ml:1mg | Category B | XC03CAB176B002010204127 | NHSA |
| Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H45020076 | 2ml:0.5mg | Category B | XC03CAB176B002010205156 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H45020960 | 2ml:0.5mg | Category B | XC03CAB176B002010205206 | NHSA |
| Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 国药准字H20057248 | 2ml:0.5mg | Category B | XC03CAB176B002010205843 | NHSA |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H20163098 | 2ml:0.5mg | Category B | XC03CAB176B002010207698 | NHSA |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20264569 | 4ml:1mg | Category B | XC03CAB176B002010209921 | NHSA |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20263011 | 1ml:0.5mg | Category B | XC03CAB176B002010282234 | NHSA |
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264071 | 4ml : 2mg | Category B | XC03CAB176B002010283094 | NHSA |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254036 | 4ml:2mg | Category B | XC03CAB176B002010283960 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249728 | 4ml:2mg | Category B | XC03CAB176B002010284135 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20254921 | 2ml:1mg | Category B | XC03CAB176B002010284534 | NHSA |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H20256036 | 4ml:2mg | Category B | XC03CAB176B002010284779 | NHSA |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255333 | 4ml:1mg | Category B | XC03CAB176B002010285074 | NHSA |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254456 | 2ml∶0.5mg | Category B | XC03CAB176B002010285135 | NHSA |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | 国药准字H20256032 | 4ml:2mg | Category B | XC03CAB176B002010285170 | NHSA |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20264515 | 2ml:1mg | Category B | XC03CAB176B002010285467 | NHSA |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256300 | 2ml:1mg | Category B | XC03CAB176B002010285482 | NHSA |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20264514 | 2ml:0.5mg | Category B | XC03CAB176B002010285560 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50021461 | 2ml:0.5mg | Category B | XC03CAB176B002010300978 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20263723 | 2ml:1mg | Category B | XC03CAB176B002010302763 | NHSA |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H20265213 | 4ml:2mg | Category B | XC03CAB176B002010304083 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263951 | 4ml:1mg | Category B | XC03CAB176B002010304127 | NHSA |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H20163098 | 2ml:0.5mg | Category B | XC03CAB176B002010307698 | NHSA |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255333 | 4ml:1mg | Category B | XC03CAB176B002010385074 | NHSA |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H20265213 | 4ml:2mg | Category B | XC03CAB176B002010404083 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263951 | 4ml:1mg | Category B | XC03CAB176B002010404127 | NHSA |
| Liaoning Yu Huang Pharma Co., Ltd. romanized | 国药准字H20083499 | 2ml:0.5mg | Category B | XC03CAB176B002020101247 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264735 | 2ml:1mg | Category B | XC03CAB176B002020101495 | NHSA |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H20057023 | 2ml:0.5mg | Category B | XC03CAB176B002020101866 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20269095 | 1ml:0.5mg | Category B | XC03CAB176B002020102087 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264440 | 1ml:0.5mg | Category B | XC03CAB176B002020102763 | NHSA |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20269077 | 1ml:0.5mg | Category B | XC03CAB176B002020103216 | NHSA |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | 国药准字H35020460 | 2ml:0.5mg | Category B | XC03CAB176B002020104827 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20057225 | 2ml:1mg | Category B | XC03CAB176B002020105206 | NHSA |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H20263066 | 1ml : 0.5mg | Category B | XC03CAB176B002020110121 | NHSA |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20269129 | 1ml:0.5mg | Category B | XC03CAB176B002020183960 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20254920 | 4ml:2mg | Category B | XC03CAB176B002020184534 | NHSA |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264479 | 1ml:0.5mg | Category B | XC03CAB176B002020184954 | NHSA |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256301 | 4ml:2mg | Category B | XC03CAB176B002020185482 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264735 | 2ml:1mg | Category B | XC03CAB176B002020201495 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264440 | 1ml:0.5mg | Category B | XC03CAB176B002020202763 | NHSA |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20269129 | 1ml:0.5mg | Category B | XC03CAB176B002020283960 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20254920 | 4ml:2mg | Category B | XC03CAB176B002020284534 | NHSA |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256301 | 4ml:2mg | Category B | XC03CAB176B002020285482 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264735 | 2ml:1mg | Category B | XC03CAB176B002020301495 | NHSA |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H20057023 | 2ml:0.5mg | Category B | XC03CAB176B002020301866 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264440 | 1ml:0.5mg | Category B | XC03CAB176B002020302763 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20057225 | 2ml:1mg | Category B | XC03CAB176B002020305206 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20264735 | 2ml:1mg | Category B | XC03CAB176B002020401495 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20057225 | 2ml:1mg | Category B | XC03CAB176B002020405206 | NHSA |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | 国药准字H20256032 | 4ml:2mg | Category B | XC03CAB176B002010385170 | 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: 13 filings and 9 distinct first applicants.
Generic 11 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600530 | Generic | 2026/02/26 | Not stated by source | CDE |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600529 | Generic | 2026/02/26 | Not stated by source | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601384 | Generic | 2026/06/11 | Not stated by source | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601382 | Generic | 2026/06/11 | Not stated by source | CDE |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | CYHB2601065 | Supplement | 2026/06/05 | Not stated by source | CDE |
| Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601212 | Generic | 2026/05/29 | Not stated by source | CDE |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | CYHB2650108 | Supplement | 2026/04/30 | Not stated by source | CDE |
| Shandong Yi Jian Pharma Co., Ltd. romanized | CYHS2503579 | Generic | 2025/09/30 | Not stated by source | CDE |
| Shandong Yi Jian Pharma Co., Ltd. romanized | CYHS2503578 | Generic | 2025/09/30 | Not stated by source | CDE |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | CYHS2502591 | Generic | 2025/07/18 | Not stated by source | CDE |
| Shandong Hui Cheng Pharma Co., Ltd. romanized | CYHS2501471 | Generic | 2025/04/17 | Not stated by source | CDE |
| Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2501196 | Generic | 2025/03/27 | Not stated by source | CDE |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | CYHS2403001 | Generic | 2024/09/11 | Not stated by source | CDE |
Loaded records: 5 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600530 | Generic | 2026/02/26 | Not stated by source | CDE |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600529 | Generic | 2026/02/26 | Not stated by source | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601384 | Generic | 2026/06/11 | Not stated by source | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601382 | Generic | 2026/06/11 | Not stated by source | CDE |
| Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601212 | Generic | 2026/05/29 | Not stated by source | CDE |
Non-component matches: 24 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 布美他尼 · No verified English name | Yi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanized | Y20260000184 | I | Exact ingredient | 2026/04/23 | CDE |
| 布美他尼 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20240000927 | A | Exact ingredient | 2026/07/13 | CDE |
| 布美他尼 · No verified English name | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | Y20240001294 | A | Exact ingredient | 2026/05/07 | CDE |
| 布美他尼 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240001211 | A | Exact ingredient | 2026/07/15 | CDE |
| 布美他尼 · No verified English name | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20240001076 | A | Exact ingredient | 2026/04/01 | CDE |
| 布美他尼 · No verified English name | Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20240000859 | A | Exact ingredient | 2026/04/21 | CDE |
| 布美他尼 · No verified English name | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | Y20240000936 | A | Exact ingredient | 2026/07/01 | CDE |
| 布美他尼 · No verified English name | Hangzhou Ao Sai Nuo Bio Technology Co., Ltd. romanized | Y20240000761 | A | Exact ingredient | 2026/03/17 | CDE |
| 布美他尼 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20240000807 | A | Exact ingredient | 2026/01/08 | CDE |
| 布美他尼 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20240000775 | A | Exact ingredient | 2026/06/23 | CDE |
| 布美他尼 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20240000623 | I | Exact ingredient | 2024/08/05 | CDE |
| 布美他尼 · No verified English name | Suzhou Li Xin Pharmaceutical Co., Ltd. romanized | Y20240000515 | A | Exact ingredient | 2025/11/26 | CDE |
| 布美他尼 · No verified English name | OLON S.P.A. | Y20240000359 | A | Exact ingredient | 2025/12/05 | CDE |
| 布美他尼 · No verified English name | Zhejiang Hao Hua Pharmaceutical Co., Ltd. romanized | Y20240000188 | A | Exact ingredient | 2025/05/28 | CDE |
| 布美他尼 · No verified English name | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20230001167 | A | Exact ingredient | 2025/07/01 | CDE |
| 布美他尼 · No verified English name | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20230001090 | A | Exact ingredient | 2025/07/18 | CDE |
| 布美他尼 · No verified English name | INDUSTRIALE CHIMICA S.R.L. | Y20230000563 | A | Exact ingredient | 2026/09/13 | CDE |
| 布美他尼 · No verified English name | Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | Y20230000614 | A | Exact ingredient | 2024/11/07 | CDE |
| 布美他尼 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20230000354 | A | Exact ingredient | 2026/03/03 | CDE |
| 布美他尼 · No verified English name | Su Zhou Yi Fan Pharma Co., Ltd. romanized | Y20230000386 | A | Exact ingredient | 2025/06/07 | CDE |
| 布美他尼 · No verified English name | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Y20230000272 | A | Exact ingredient | 2026/08/15 | CDE |
| 布美他尼 · No verified English name | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20220001296 | A | Exact ingredient | 2026/01/22 | CDE |
| 布美他尼 · No verified English name | Solara Active Pharma Sciences Limited | Y20210001128 | I | Exact ingredient | 2022/02/23 | CDE |
| 布美他尼 · No verified English name | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190007367 | A | Exact ingredient | — | CDE |
| 布美他尼 · No verified English name | Gui Lin Nan Yao Co., Ltd. romanized | Y20190004090 | A | Exact ingredient | 2025/01/18 | CDE |
| 布美他尼 · No verified English name | Hainan Wu Ren Pharmaceutical Co., Ltd. romanized | Y20190002887 | A | Exact ingredient | 2024/09/05 | CDE |
| 布美他尼 · No verified English name | Ningbo Da Hong Ying Pharma Co., Ltd. romanized | Y20190002459 | A | Exact ingredient | 2025/01/03 | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
CYHS2502623
Fact date: 2026/11/09 (Publication date) · Publication date: 2026/11/09 · Site observation date: 2026/11/09
Notification delivered; the specific outcome remains to be checked.
View source · Table row 4 ↗CYHS2501389
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2025/04/10
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2500702
Fact date: 2026/11/06 · Site observation date: 2026/11/06
Accepted: 2025/02/12
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2500701
Fact date: 2026/11/06 · Site observation date: 2026/11/06
Accepted: 2025/02/12
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501608
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2025/04/29
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501821 · 国药准字H20266291
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 66 ↗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: 2026-10-29 to 2026-11-13; 2 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: 7/30; discovered pending details: 13. 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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