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Sign in to subscribeAs of 13 November 2026, for Bisoprolol Fumarate Tablets, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 17 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applicationsNo longer listed under review: 2 applications
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 1 of 1 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: Tablets. 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 |
|---|---|---|---|---|---|---|
| ZEBETA | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC | NDA 019982 · Product no. 001, 002 | TABLET | ORAL | DISCONTINUED | 1992/07/31 |
No listings in this group among the displayed brand names.
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: 17 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 12 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 |
|---|---|---|---|---|---|---|
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264341 | 2026/05/19 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264340 | 2026/05/19 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Giantech Hi-technology Development Co., Ltd. | Sichuan Sai Zhuo Pharma Co., Ltd. romanized | 国药准字H20263845 | 2026/04/07 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Giantech Hi-technology Development Co., Ltd. | Sichuan Sai Zhuo Pharma Co., Ltd. romanized | 国药准字H20263844 | 2026/04/07 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Jian Hui Le Xiang Pharmaceuticals Technology Co., Ltd. romanized | Shanghai Heng Shan Pharma Co., Ltd. romanized | 国药准字H20263006 | 2026/01/05 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Jian Hui Le Xiang Pharmaceuticals Technology Co., Ltd. romanized | Shanghai Heng Shan Pharma Co., Ltd. romanized | 国药准字H20263005 | 2026/01/05 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255877 | 2025/11/04 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255876 | 2025/11/04 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255640 | 2025/09/30 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255641 | 2025/09/30 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254341 | 2025/05/27 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254340 | 2025/05/27 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | 国药准字H20253940 | 2025/04/15 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | 国药准字H20253939 | 2025/04/15 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20253012 | 2025/01/02 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20253013 | 2025/01/02 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 2024/09/03 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2024/09/03 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243947 | 2024/06/04 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243946 | 2024/06/04 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20243348 | 2024/03/19 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 国药准字H20243009 | 2024/01/09 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 国药准字H20243010 | 2024/01/09 | 2.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hexal AG | Lek S.A. | 国药准字HJ20170261 | 2023/04/28 | 5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hexal AG | Lek S. A. | 国药准字HJ20170259 | 2023/03/22 | 5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 2020/05/22 | 5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083007 | 2020/01/07 | 2.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H20023132 | 2019/06/21 | 2.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H10970082 | 2019/06/21 | 5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083008 | 2018/07/20 | 5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Merck Serono GmbH | Merck KGaA | H20160475 | 2005/09/15 | 2.5mg | Imported originator drug | CDE |
| Merck Serono GmbH | Merck KGaA | H20160474 | 1995/06/08 | 5mg | Imported originator drug | 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: 32 distinct approval numbers and 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H20023132 | 2.5mg | Category A | XC07ABB087A001010100052 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083007 | 2.5mg | Category A | XC07ABB087A001010102181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255876 | 5mg | Category A | XC07ABB087A001010102251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010102877 | NHSA |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20253012 | 5mg | Category A | XC07ABB087A001010103783 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255640 | 5mg | Category A | XC07ABB087A001010104187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243946 | 2.5mg | Category A | XC07ABB087A001010104658 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 5mg | Category A | XC07ABB087A001010104918 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253939 | 2.5mg | Category A | XC07ABB087A001010104960 | NHSA |
| Hexal AG | 国药准字HJ20170259 | 5mg | Category A | XC07ABB087A001010178495 | NHSA |
| Merck Serono GmbH | H20160475 | 2.5mg | Category A | XC07ABB087A001010179462 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263845 | 5mg | Category A | XC07ABB087A001010183325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010183781 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20243348 | 5mg | Category A | XC07ABB087A001010184240 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264340 | 5mg | Category A | XC07ABB087A001010185558 | NHSA |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H20023132 | 2.5mg | Category A | XC07ABB087A001010200052 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083007 | 2.5mg | Category A | XC07ABB087A001010202181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255876 | 5mg | Category A | XC07ABB087A001010202251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010202877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255640 | 5mg | Category A | XC07ABB087A001010204187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243946 | 2.5mg | Category A | XC07ABB087A001010204658 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 5mg | Category A | XC07ABB087A001010204918 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253939 | 2.5mg | Category A | XC07ABB087A001010204960 | NHSA |
| Salutas Pharma GmbH | 国药准字J20171043 | 5mg | Category A | XC07ABB087A001010209659 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263845 | 5mg | Category A | XC07ABB087A001010283325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010283781 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20243348 | 5mg | Category A | XC07ABB087A001010284240 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083007 | 2.5mg | Category A | XC07ABB087A001010302181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255876 | 5mg | Category A | XC07ABB087A001010302251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010302877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255640 | 5mg | Category A | XC07ABB087A001010304187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243946 | 2.5mg | Category A | XC07ABB087A001010304658 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 5mg | Category A | XC07ABB087A001010304918 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253939 | 2.5mg | Category A | XC07ABB087A001010304960 | NHSA |
| Lek.S.A. | 国药准字HJ20170261 | 5mg | Category A | XC07ABB087A001010378495 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263845 | 5mg | Category A | XC07ABB087A001010383325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010383781 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20243348 | 5mg | Category A | XC07ABB087A001010384240 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255876 | 5mg | Category A | XC07ABB087A001010402251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010402877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255640 | 5mg | Category A | XC07ABB087A001010404187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243946 | 2.5mg | Category A | XC07ABB087A001010404658 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 5mg | Category A | XC07ABB087A001010404918 | NHSA |
| Hexal AG | 国药准字HJ20170259 | 5mg | Category A | XC07ABB087A001010478495 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263845 | 5mg | Category A | XC07ABB087A001010483325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010483781 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20243348 | 5mg | Category A | XC07ABB087A001010484240 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255876 | 5mg | Category A | XC07ABB087A001010502251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010502877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255640 | 5mg | Category A | XC07ABB087A001010504187 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254340 | 2.5mg | Category A | XC07ABB087A001010504188 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 5mg | Category A | XC07ABB087A001010504918 | NHSA |
| Lek.S.A. | 国药准字HJ20170261 | 5mg | Category A | XC07ABB087A001010578495 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010583781 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20243348 | 5mg | Category A | XC07ABB087A001010584240 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010602877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255640 | 5mg | Category A | XC07ABB087A001010604187 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254340 | 2.5mg | Category A | XC07ABB087A001010604188 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20173037 | 5mg | Category A | XC07ABB087A001010604918 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010683781 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20243348 | 5mg | Category A | XC07ABB087A001010684240 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010702877 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254340 | 2.5mg | Category A | XC07ABB087A001010704188 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010783781 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244793 | 2.5mg | Category A | XC07ABB087A001010802877 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254340 | 2.5mg | Category A | XC07ABB087A001010804188 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010883781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001010983781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011083781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011183781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011283781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011383781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011483781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011583781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011683781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011783781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011883781 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243009 | 5mg | Category A | XC07ABB087A001011983781 | NHSA |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H10970082 | 5mg | Category A | XC07ABB087A001020100052 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083008 | 5mg | Category A | XC07ABB087A001020102181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255877 | 2.5mg | Category A | XC07ABB087A001020102251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020102877 | NHSA |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20253013 | 2.5mg | Category A | XC07ABB087A001020103783 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255641 | 2.5mg | Category A | XC07ABB087A001020104187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243947 | 5mg | Category A | XC07ABB087A001020104658 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253940 | 5mg | Category A | XC07ABB087A001020104960 | NHSA |
| Merck Healthcare Germany GmbH | 国药准字HJ20160474 | 5mg | Category A | XC07ABB087A001020179462 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263844 | 2.5mg | Category A | XC07ABB087A001020183325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243010 | 2.5mg | Category A | XC07ABB087A001020183781 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264340 | 5mg | Category A | XC07ABB087A001020185558 | NHSA |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H10970082 | 5mg | Category A | XC07ABB087A001020200052 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083008 | 5mg | Category A | XC07ABB087A001020202181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255877 | 2.5mg | Category A | XC07ABB087A001020202251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020202877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255641 | 2.5mg | Category A | XC07ABB087A001020204187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243947 | 5mg | Category A | XC07ABB087A001020204658 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253940 | 5mg | Category A | XC07ABB087A001020204960 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263844 | 2.5mg | Category A | XC07ABB087A001020283325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243010 | 2.5mg | Category A | XC07ABB087A001020283781 | NHSA |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H10970082 | 5mg | Category A | XC07ABB087A001020300052 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083008 | 5mg | Category A | XC07ABB087A001020302181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255877 | 2.5mg | Category A | XC07ABB087A001020302251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020302877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255641 | 2.5mg | Category A | XC07ABB087A001020304187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243947 | 5mg | Category A | XC07ABB087A001020304658 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253940 | 5mg | Category A | XC07ABB087A001020304960 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263844 | 2.5mg | Category A | XC07ABB087A001020383325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243010 | 2.5mg | Category A | XC07ABB087A001020383781 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20083008 | 5mg | Category A | XC07ABB087A001020402181 | NHSA |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20255877 | 2.5mg | Category A | XC07ABB087A001020402251 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020402877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255641 | 2.5mg | Category A | XC07ABB087A001020404187 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20243947 | 5mg | Category A | XC07ABB087A001020404658 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253940 | 5mg | Category A | XC07ABB087A001020404960 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20263844 | 2.5mg | Category A | XC07ABB087A001020483325 | NHSA |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H20243010 | 2.5mg | Category A | XC07ABB087A001020483781 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020502877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255641 | 2.5mg | Category A | XC07ABB087A001020504187 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254341 | 5mg | Category A | XC07ABB087A001020504188 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253940 | 5mg | Category A | XC07ABB087A001020504960 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020602877 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255641 | 2.5mg | Category A | XC07ABB087A001020604187 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254341 | 5mg | Category A | XC07ABB087A001020604188 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20253940 | 5mg | Category A | XC07ABB087A001020604960 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020702877 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254341 | 5mg | Category A | XC07ABB087A001020704188 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020802877 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20254341 | 5mg | Category A | XC07ABB087A001020804188 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001020902877 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20244794 | 5mg | Category A | XC07ABB087A001021002877 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264340 | 5mg | Category A | XC07ABB087A001030185558 | NHSA |
| Mo Ke Pharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H20205006 | 5mg | Category A | XC07ABB087A001040181152 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264340 | 5mg | Category A | XC07ABB087A001040185558 | NHSA |
| Mo Ke Pharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H20205006 | 5mg | Category A | XC07ABB087A001040381152 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264341 | 2.5mg | Category A | XC07ABB087A001050185558 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264341 | 2.5mg | Category A | XC07ABB087A001060185558 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264341 | 2.5mg | Category A | XC07ABB087A001070185558 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264341 | 2.5mg | Category A | XC07ABB087A001080185558 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264340 | 5mg | Category A | XC07ABB087A001090185558 | NHSA |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264341 | 2.5mg | Category A | XC07ABB087A001100185558 | 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: 6 filings and 3 distinct first applicants.
Supplement 2 · Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHB2601921 | Supplement | 2026/10/21 | Not stated by source | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHB2601920 | Supplement | 2026/10/21 | Not stated by source | CDE |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601728 | Generic | 2026/07/20 | Not stated by source | CDE |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601727 | Generic | 2026/07/20 | Not stated by source | CDE |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600046 | Generic | 2026/01/06 | Not stated by source | CDE |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600045 | Generic | 2026/01/06 | Not stated by source | CDE |
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601728 | Generic | 2026/07/20 | Not stated by source | CDE |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601727 | Generic | 2026/07/20 | Not stated by source | CDE |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600046 | Generic | 2026/01/06 | Not stated by source | CDE |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600045 | Generic | 2026/01/06 | Not stated by source | CDE |
Non-component matches: 10 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 |
|---|---|---|---|---|---|---|
| 富马酸比索洛尔 · No verified English name | MANGALAM DRUGS & ORGANICS LIMITED | Y20230000663 | I | Exact ingredient | 2025/06/13 | CDE |
| 富马酸比索洛尔 · No verified English name | UNICHEM LABORATORIES LIMITED | Y20200000629 | A | Exact ingredient | 2023/02/08 | CDE |
| 富马酸比索洛尔 · No verified English name | Xin Dong Sheng Ji Co., Ltd. romanized | Y20190021601 | A | Exact ingredient | 2024/05/17 | CDE |
| 富马酸比索洛尔 · No verified English name | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20190006118 | A | Exact ingredient | 2025/07/10 | CDE |
| 富马酸比索洛尔 · No verified English name | Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | Y20190005788 | A | Exact ingredient | 2026/09/29 | CDE |
| 富马酸比索洛尔 · No verified English name | Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20190005732 | A | Exact ingredient | 2025/12/17 | CDE |
| 富马酸比索洛尔 · No verified English name | Beijing Hua Su Pharmaceutical Co., Ltd. romanized | Y20190004497 | A | Exact ingredient | 2024/01/17 | CDE |
| 富马酸比索洛尔 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20190001402 | A | Exact ingredient | 2024/07/18 | CDE |
| 富马酸比索洛尔 · No verified English name | MOEHS IBERICA S.L. | Y20180000720 | I | Exact ingredient | 2018/08/01 | CDE |
| 富马酸比索洛尔 · No verified English name | Taiwan Biotech Co.,Ltd. | Y20170001503 | A | Exact ingredient | 2026/01/14 | CDE |
| 富马酸比索洛尔 · No verified English name | Ipca Laboratories Limited | Y20170001028 | A | Exact ingredient | 2026/04/28 | CDE |
| 富马酸比索洛尔 · No verified English name | Merck KGaA | Y20170000769 | A | Exact ingredient | 2025/10/19 | 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.
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.
CYHS2504503
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/12/31
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2504502
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/12/31
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHB2601921
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗CYHB2601920
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗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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