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Sign in to subscribeAs of 13 November 2026, for Ezetimibe Tablets, 4 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 21 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as ZETIA (NDA 021445, ORGANON LLC A SUB OF ORGANON AND CO).
Last 90 days: Accepted: 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 |
|---|---|---|---|---|---|---|
| ZETIA | ORGANON LLC A SUB OF ORGANON AND CO | NDA 021445 · Product no. 001 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2002/10/25 |
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: 21 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 19 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 |
|---|---|---|---|---|---|---|
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20265564 | 2026/08/04 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized | Beijing Ya Bao Bio Pharma Co., Ltd. romanized | 国药准字H20264396 | 2026/05/19 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20264237 | 2026/05/07 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hetero Labs Limited | Hetero Labs Limited | 国药准字HJ20260034 | 2026/04/14 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20263459 | 2026/02/25 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | Jiangsu Fu Dan Fu Hua Pharma Co., Ltd. romanized | 国药准字H20256139 | 2025/12/03 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20253162 | 2025/01/14 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | Kunming Long Jin Pharma Co., Ltd. romanized | 国药准字H20249818 | 2024/12/25 | 10mg | Not stated by source | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 2024/12/17 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 2024/12/01 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Bai Ao Pharma Co., Ltd. romanized | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H20249171 | 2024/10/22 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244067 | 2024/06/18 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 国药准字H20243762 | 2024/05/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 2024/02/23 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Jing Pharma Co., Ltd. romanized | Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20233164 | 2023/02/14 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | 国药准字H20213760 | 2021/09/30 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20213584 | 2021/07/20 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20213585 | 2021/07/20 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sandoz Inc. | Lek Pharmaceuticals d. d. | 国药准字HJ20210050 | 2021/06/29 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 2020/09/08 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| MSD Pharma (Singapore) Pte. Ltd. | MSD International GmbH (Singapore Branch) | H20160181 | 2006/04/06 | 10mg | 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: 23 distinct approval numbers and 23 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20264237 | 10mg | Category B | XC10AXY097A001010100111 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20213584 | 10mg | Category B | XC10AXY097A001010100177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244067 | 10mg | Category B | XC10AXY097A001010101397 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20213760 | 10mg | Category B | XC10AXY097A001010101504 | NHSA |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233164 | 10mg | Category B | XC10AXY097A001010101564 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010104188 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J20171023 | 10mg | Category B | XC10AXY097A001010104495 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010104920 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20265564 | 10mg | Category B | XC10AXY097A001010104960 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20263459 | 10mg | Category B | XC10AXY097A001010105356 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010106632 | NHSA |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized | 国药准字H20264396 | 10mg | Category B | XC10AXY097A001010109542 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20213585 | 10mg | Category B | XC10AXY097A001010109568 | NHSA |
| MSD International GmbH (Singapore Branch) | H20160181 | 10mg | Category B | XC10AXY097A001010178893 | NHSA |
| Hetero Labs Limited | 国药准字HJ20260034 | 10mg | Category B | XC10AXY097A001010179426 | NHSA |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20243762 | 10mg | Category B | XC10AXY097A001010180472 | NHSA |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H20249171 | 10mg | Category B | XC10AXY097A001010183058 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20253162 | 10mg | Category B | XC10AXY097A001010183198 | NHSA |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H20256139 | 10mg | Category B | XC10AXY097A001010183356 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010183521 | NHSA |
| Sandoz Inc. | 国药准字HJ20210050 | 10mg | Category B | XC10AXY097A001010183662 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010184548 | NHSA |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20264237 | 10mg | Category B | XC10AXY097A001010200111 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20213584 | 10mg | Category B | XC10AXY097A001010200177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244067 | 10mg | Category B | XC10AXY097A001010201397 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20213760 | 10mg | Category B | XC10AXY097A001010201504 | NHSA |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233164 | 10mg | Category B | XC10AXY097A001010201564 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010204188 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J20171023 | 10mg | Category B | XC10AXY097A001010204495 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010204920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010206632 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20213585 | 10mg | Category B | XC10AXY097A001010209568 | NHSA |
| MSD International GmbH (Singapore Branch) | H20160181 | 10mg | Category B | XC10AXY097A001010278893 | NHSA |
| Hetero Labs Limited | 国药准字HJ20260034 | 10mg | Category B | XC10AXY097A001010279426 | NHSA |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H20249171 | 10mg | Category B | XC10AXY097A001010283058 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20253162 | 10mg | Category B | XC10AXY097A001010283198 | NHSA |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H20256139 | 10mg | Category B | XC10AXY097A001010283356 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010283521 | NHSA |
| Sandoz Inc. | 国药准字HJ20210050 | 10mg | Category B | XC10AXY097A001010283662 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010284548 | NHSA |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20264237 | 10mg | Category B | XC10AXY097A001010300111 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20213584 | 10mg | Category B | XC10AXY097A001010300177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244067 | 10mg | Category B | XC10AXY097A001010301397 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20213760 | 10mg | Category B | XC10AXY097A001010301504 | NHSA |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233164 | 10mg | Category B | XC10AXY097A001010301564 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010304188 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J20171023 | 10mg | Category B | XC10AXY097A001010304495 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010304920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010306632 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20213585 | 10mg | Category B | XC10AXY097A001010309568 | NHSA |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ20160181 | 10mg | Category B | XC10AXY097A001010378893 | NHSA |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H20249171 | 10mg | Category B | XC10AXY097A001010383058 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20253162 | 10mg | Category B | XC10AXY097A001010383198 | NHSA |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H20256139 | 10mg | Category B | XC10AXY097A001010383356 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010383521 | NHSA |
| Sandoz Inc. | 国药准字HJ20210050 | 10mg | Category B | XC10AXY097A001010383662 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010384548 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20213584 | 10mg | Category B | XC10AXY097A001010400177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244067 | 10mg | Category B | XC10AXY097A001010401397 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20213760 | 10mg | Category B | XC10AXY097A001010401504 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010404188 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010404920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010406632 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20213585 | 10mg | Category B | XC10AXY097A001010409568 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20253162 | 10mg | Category B | XC10AXY097A001010483198 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010483521 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010484548 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20213584 | 10mg | Category B | XC10AXY097A001010500177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244067 | 10mg | Category B | XC10AXY097A001010501397 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20213760 | 10mg | Category B | XC10AXY097A001010501504 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010504188 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010504920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010506632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010583521 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010584548 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010604188 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010604920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010606632 | NHSA |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ20160181 | 10mg | Category B | XC10AXY097A001010678893 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010683521 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010684548 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010704188 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010704920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010706632 | NHSA |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ20160181 | 10mg | Category B | XC10AXY097A001010778893 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010783521 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010784548 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010804188 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010804920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010806632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010883521 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249818 | 10mg | Category B | XC10AXY097A001010884548 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249737 | 10mg | Category B | XC10AXY097A001010904188 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001010904920 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20249498 | 10mg | Category B | XC10AXY097A001010906632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001010983521 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001011004920 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011083521 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001011104920 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011183521 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001011204920 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011283521 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001011304920 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011383521 | NHSA |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203468 | 10mg | Category B | XC10AXY097A001011404920 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001011983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243253 | 10mg | Category B | XC10AXY097A001012683521 | 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: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601395 | Generic | 2026/06/12 | Not stated by source | CDE |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | CYHS2602544 | Generic | 2026/10/14 | Not stated by source | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2504117 | Generic | 2025/12/02 | Not stated by source | CDE |
| Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | CYHS2602594 | Generic | 2026/10/22 | Not stated by source | CDE |
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601395 | Generic | 2026/06/12 | Not stated by source | CDE |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | CYHS2602544 | Generic | 2026/10/14 | Not stated by source | CDE |
| Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | CYHS2602594 | Generic | 2026/10/22 | Not stated by source | CDE |
Non-component matches: 20 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 依折麦布 · No verified English name | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | Y20260000100 | I | Exact ingredient | 2026/02/11 | CDE |
| 依折麦布 · No verified English name | Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20250000915 | I | Exact ingredient | 2025/10/30 | CDE |
| 依折麦布 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000047 | A | Exact ingredient | 2026/07/20 | CDE |
| 依折麦布 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20240001567 | A | Exact ingredient | 2026/07/14 | CDE |
| 依折麦布 · No verified English name | Saptagir Laboratories Pvt. Ltd. | Y20240000581 | I | Exact ingredient | 2026/04/03 | CDE |
| 依折麦布 · No verified English name | Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20230001252 | A | Exact ingredient | 2025/07/11 | CDE |
| 依折麦布 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20230000515 | A | Exact ingredient | 2024/09/02 | CDE |
| 依折麦布 · No verified English name | Apitoria Pharma Private Limited | Y20230000079 | A | Exact ingredient | 2025/01/06 | CDE |
| 依折麦布 · No verified English name | Hetero Labs Limited | Y20220000766 | A | Exact ingredient | 2026/03/19 | CDE |
| 依折麦布 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20220000666 | A | Exact ingredient | 2026/02/10 | CDE |
| 依折麦布 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20210000966 | A | Exact ingredient | 2023/08/29 | CDE |
| 依折麦布 · No verified English name | Hanmi Fine Chemical Co., Ltd. | Y20200001433 | A | Exact ingredient | 2024/10/24 | CDE |
| 依折麦布 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20210000182 | A | Exact ingredient | 2022/11/02 | CDE |
| 依折麦布 · No verified English name | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Y20210000199 | A | Exact ingredient | 2023/02/21 | CDE |
| 依折麦布 · No verified English name | LUPIN LIMITED | Y20210000140 | A | Exact ingredient | 2025/05/17 | CDE |
| 依折麦布 · No verified English name | Shandong Bo Yuan Pharma Co., Ltd. romanized | Y20200001270 | A | Exact ingredient | 2024/02/27 | CDE |
| 依折麦布 · No verified English name | Synthimed Labs Private Limited | Y20200001218 | A | Exact ingredient | 2026/07/17 | CDE |
| 依折麦布 · No verified English name | Neuland Laboratories Ltd | Y20200000801 | I | Exact ingredient | 2020/12/22 | CDE |
| 依折麦布 · No verified English name | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20200000290 | A | Exact ingredient | 2022/10/27 | CDE |
| 依折麦布 · No verified English name | Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20190000721 | A | Exact ingredient | 2026/01/06 | CDE |
| 依折麦布 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190000874 | A | Exact ingredient | 2026/04/30 | CDE |
| 依折麦布 · No verified English name | TEVA API INDIA PRIVATE LIMITED | Y20190000329 | A | Exact ingredient | 2026/07/15 | CDE |
| 依折麦布 · No verified English name | Aurobindo Pharma Limited | Y20180001595 | I | Exact ingredient | 2019/03/20 | CDE |
| 依折麦布 · No verified English name | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | Y20190000024 | A | Exact ingredient | 2025/09/16 | CDE |
| 依折麦布 · No verified English name | MSN Laboratories Private Limited Yi De Pharma (Shanghai) Co., Ltd. romanized | Y20180001083 | A | Exact ingredient | 2025/07/30 | CDE |
| 依折麦布 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20180001036 | I | Exact ingredient | 2018/08/30 | 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.
CYHS2602594
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗CYHS2602544
Fact date: 2026/10/14 · 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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