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Sign in to subscribeAs of 13 November 2026, for Moxifloxacin Hydrochloride Tablets, 11 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 29 holders.
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
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 4 of 4 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 |
|---|---|---|---|---|---|---|
| AVELOX | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 021085 · Product no. 001 | TABLET | ORAL | DISCONTINUED | 1999/12/10 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| VIGAMOX | HARROW EYE LLC | NDA 021598 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | HUMAN PRESCRIPTION DRUG | 2003/04/15 |
| AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 021277 · Product no. 001 | SOLUTION | INTRAVENOUS | DISCONTINUED | 2001/11/30 |
| MOXEZA | HARROW EYE LLC | NDA 022428 · Product no. 001 | SOLUTION/DROPS | OPHTHALMIC | DISCONTINUED | 2010/11/19 |
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: 29 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 27 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Xin Tian Di Pharma Co., Ltd. romanized | Xu Chang Wei Lai Pharmaceutical Co., Ltd. romanized | 国药准字H20264303 | 2026/05/12 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20264233 | 2026/05/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | 2026/03/31 | See source | 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H20256080 | 2025/11/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Di Fei Te Pharma Co., Ltd. romanized | Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20255081 | 2025/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | 2025/06/30 | See source | 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H20253145 | 2025/01/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | 2025/01/08 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634 | 2024/08/05 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | 2024/06/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077 | 2024/06/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577 | 2023/05/19 | See source | 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H20223006 | 2022/01/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized | Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851 | 2021/11/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213609 | 2021/07/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20213553 | 2021/06/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | 2021/06/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| HEXAL AG | S.C. Sandoz S.R.L. | 国药准字HJ20210032 | 2021/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323 | 2021/04/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203516 | 2020/10/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20203433 | 2020/08/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203062 | 2020/02/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Sheng He Pharma Co., Ltd. romanized | Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H20193432 | 2019/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20193406 | 2019/12/26 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20193387 | 2019/12/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | 2019/12/17 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | 2018/12/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20183246 | 2018/07/06 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Bayer Vital GmbH | Bayer Pharma AG | H20140721;H20140722;H20140723 | 2002/08/30 | 0.4g | 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 29 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Bayer Vital GmbH | 国药准字J20150015 | 0.4g | Category B | XJ01MAM122A001010100002 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | See source | Category B | XJ01MAM122A001010100177 | NHSA |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203062 | See source | Category B | XJ01MAM122A001010100553 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010100601 | NHSA |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20193406 | See source | Category B | XJ01MAM122A001010101003 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010101467 | NHSA |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H20193432 | See source | Category B | XJ01MAM122A001010101583 | NHSA |
| Sichuan Di Fei Te Pharma Co., Ltd. romanized | 国药准字H20255081 | See source | Category B | XJ01MAM122A001010102064 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203516 | See source | Category B | XJ01MAM122A001010102180 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010102662 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006 | See source | Category B | XJ01MAM122A001010102763 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010102877 | NHSA |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20256080 | See source | Category B | XJ01MAM122A001010103783 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010104127 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213609 | See source | Category B | XJ01MAM122A001010104152 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577 | See source | Category B | XJ01MAM122A001010104565 | NHSA |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367 | See source | Category B | XJ01MAM122A001010104641 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010104914 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851 | See source | Category B | XJ01MAM122A001010105206 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246 | See source | Category B | XJ01MAM122A001010106988 | NHSA |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20203433 | See source | Category B | XJ01MAM122A001010109604 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140721 | 0.4g | Category B | XJ01MAM122A001010178271 | NHSA |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20193387 | See source | Category B | XJ01MAM122A001010180542 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001010180937 | NHSA |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077 | See source | Category B | XJ01MAM122A001010181012 | NHSA |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20213553 | See source | Category B | XJ01MAM122A001010182147 | NHSA |
| Xin Tian Di Pharma Co., Ltd. romanized | 国药准字H20264303 | See source | Category B | XJ01MAM122A001010182462 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634 | See source | Category B | XJ01MAM122A001010183198 | NHSA |
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264233 | See source | Category B | XJ01MAM122A001010183546 | NHSA |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323 | See source | Category B | XJ01MAM122A001010183586 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | See source | Category B | XJ01MAM122A001010200177 | NHSA |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203062 | See source | Category B | XJ01MAM122A001010200553 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010200601 | NHSA |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20193406 | See source | Category B | XJ01MAM122A001010201003 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010201467 | NHSA |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H20193432 | See source | Category B | XJ01MAM122A001010201583 | NHSA |
| Sichuan Di Fei Te Pharma Co., Ltd. romanized | 国药准字H20255081 | See source | Category B | XJ01MAM122A001010202064 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203516 | See source | Category B | XJ01MAM122A001010202180 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010202662 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006 | See source | Category B | XJ01MAM122A001010202763 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010202877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010204127 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213609 | See source | Category B | XJ01MAM122A001010204152 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577 | See source | Category B | XJ01MAM122A001010204565 | NHSA |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367 | See source | Category B | XJ01MAM122A001010204641 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010204914 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851 | See source | Category B | XJ01MAM122A001010205206 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246 | See source | Category B | XJ01MAM122A001010206988 | NHSA |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20203433 | See source | Category B | XJ01MAM122A001010209604 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140722 | 0.4g | Category B | XJ01MAM122A001010278271 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001010280937 | NHSA |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077 | See source | Category B | XJ01MAM122A001010281012 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634 | See source | Category B | XJ01MAM122A001010283198 | NHSA |
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264233 | See source | Category B | XJ01MAM122A001010283546 | NHSA |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323 | See source | Category B | XJ01MAM122A001010283586 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | See source | Category B | XJ01MAM122A001010300177 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010300601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010301467 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010302662 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006 | See source | Category B | XJ01MAM122A001010302763 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010302877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010304127 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577 | See source | Category B | XJ01MAM122A001010304565 | NHSA |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367 | See source | Category B | XJ01MAM122A001010304641 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010304914 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851 | See source | Category B | XJ01MAM122A001010305206 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140722 | 0.4g | Category B | XJ01MAM122A001010378271 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001010380937 | NHSA |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077 | See source | Category B | XJ01MAM122A001010381012 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | See source | Category B | XJ01MAM122A001010400177 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010400601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010401467 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010402662 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010402877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010404127 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577 | See source | Category B | XJ01MAM122A001010404565 | NHSA |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367 | See source | Category B | XJ01MAM122A001010404641 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010404914 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851 | See source | Category B | XJ01MAM122A001010405206 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | See source | Category B | XJ01MAM122A001010500177 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010500601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010501467 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010502662 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010502877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010504127 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577 | See source | Category B | XJ01MAM122A001010504565 | NHSA |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367 | See source | Category B | XJ01MAM122A001010504641 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010504914 | NHSA |
| Bayer Vital GmbH | 国药准字HJ20140723 | 0.4g | Category B | XJ01MAM122A001010578271 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096 | See source | Category B | XJ01MAM122A001010600177 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010600601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010601467 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010602662 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010602877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010604127 | NHSA |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367 | See source | Category B | XJ01MAM122A001010604641 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010604914 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010700601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010701467 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010702662 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010702877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010704127 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010704914 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010800601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010801467 | NHSA |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104 | See source | Category B | XJ01MAM122A001010802662 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010802877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010804127 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500 | See source | Category B | XJ01MAM122A001010804914 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001010900601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001010901467 | NHSA |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145 | See source | Category B | XJ01MAM122A001010902877 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001010904127 | NHSA |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689 | See source | Category B | XJ01MAM122A001011000601 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001011001467 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001011004127 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001011101467 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001011104127 | NHSA |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079 | See source | Category B | XJ01MAM122A001011201467 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001011204127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001011304127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001011404127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789 | See source | Category B | XJ01MAM122A001011504127 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246 | See source | Category B | XJ01MAM122A001020106988 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001020180937 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634 | See source | Category B | XJ01MAM122A001020183198 | NHSA |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323 | See source | Category B | XJ01MAM122A001020183586 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001020280937 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634 | See source | Category B | XJ01MAM122A001020283198 | NHSA |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323 | See source | Category B | XJ01MAM122A001020283586 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001020380937 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634 | See source | Category B | XJ01MAM122A001020383198 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001020480937 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530 | See source | Category B | XJ01MAM122A001020580937 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246 | See source | Category B | XJ01MAM122A001030106988 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246 | See source | Category B | XJ01MAM122A001040106988 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Loaded records: 11 filings and 8 distinct first applicants.
Supplement 5 · Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l. | JYHB2600455 | Supplement | 2026/08/12 | Not stated by source | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | CYHB2600779 | Supplement | 2026/04/18 | Not stated by source | CDE |
| Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanized | CYHS2600411 | Generic | 2026/02/09 | Not stated by source | CDE |
| Bei Da Pharmaceuticals Co., Ltd. romanized | CYHS2600143 | Generic | 2026/01/12 | Not stated by source | CDE |
| Jiangxi Hong Shuo Pharmaceutical Co., Ltd. romanized | CYHS2504102 | Generic | 2025/11/28 | Not stated by source | CDE |
| Zhengzhou Han Dou Pharma Group Co., Ltd. romanized | CYHS2503969 | Generic | 2025/11/15 | Not stated by source | CDE |
| Jilin Dao Jun Pharma Co., Ltd. romanized | CYHS2503917 | Generic | 2025/11/11 | Not stated by source | CDE |
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l.; Name not romanized | JYHB2500581 | Supplement | 2025/10/31 | Not stated by source | CDE |
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l. | JYHB2500580 | Supplement | 2025/10/31 | Not stated by source | CDE |
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l. | JYHB2500579 | Supplement | 2025/10/31 | Not stated by source | CDE |
| Hainan Hai Li Pharmaceutical Co., Ltd. romanized | CYHS2501805 | Generic | 2025/05/17 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanized | CYHS2600411 | Generic | 2026/02/09 | Not stated by source | CDE |
| Bei Da Pharmaceuticals Co., Ltd. romanized | CYHS2600143 | Generic | 2026/01/12 | Not stated by source | CDE |
Non-component matches: 48 companies with A status and 16 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 盐酸莫西沙星 · No verified English name | Jiangxi Shan Yuan Pharma Co., Ltd. romanized | Y20260000402 | I | Exact ingredient | 2026/09/17 | CDE |
| 盐酸莫西沙星 · No verified English name | Jiangxi Xiang Tai Sheng Ming Ke Xue Co., Ltd. romanized | Y20240000879 | I | Exact ingredient | 2024/08/23 | CDE |
| 盐酸莫西沙星 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230001071 | A | Exact ingredient | 2025/07/22 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Xin He Cheng Co., Ltd. romanized | Y20230000900 | A | Exact ingredient | 2026/03/31 | CDE |
| 盐酸莫西沙星 · No verified English name | Hebei Tian Cheng Pharma Co., Ltd. romanized | Y20220000887 | A | Exact ingredient | 2024/07/09 | CDE |
| 盐酸莫西沙星 · No verified English name | Hebei Kai Wei Kang Ling Pharmaceutical Co., Ltd. romanized | Y20220000860 | A | Exact ingredient | 2024/12/04 | CDE |
| 盐酸莫西沙星 · No verified English name | Shandong Lukang Pharmaceutical Co.,Ltd. | Y20220000493 | A | Exact ingredient | 2025/12/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Xian Wan Long Pharmaceutical Co., Ltd. romanized | Y20220000473 | I | Exact ingredient | 2022/07/05 | CDE |
| 盐酸莫西沙星 · No verified English name | Yi Chang Dong Yang Guang Pharmaceutical Co., Ltd. romanized | Y20220000196 | A | Exact ingredient | 2025/09/06 | CDE |
| 盐酸莫西沙星 · No verified English name | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20220000100 | A | Exact ingredient | 2025/06/07 | CDE |
| 盐酸莫西沙星 · No verified English name | Changzhou Hong Tai Yang Pharma Co., Ltd. romanized | Y20210001254 | A | Exact ingredient | 2024/04/28 | CDE |
| 盐酸莫西沙星 · No verified English name | Chongqing Shi Nan An Qu Jiang Qiao Lu 8 Hao romanized | Y20210001098 | A | Exact ingredient | 2026/07/16 | CDE |
| 盐酸莫西沙星 · No verified English name | Xin Tian Di Pharma Co., Ltd. romanized | Y20210000980 | A | Exact ingredient | 2026/02/27 | CDE |
| 盐酸莫西沙星 · No verified English name | Anhui Jian Feng Bei Ka Pharma Co., Ltd. romanized | Y20210000527 | A | Exact ingredient | 2025/12/23 | CDE |
| 盐酸莫西沙星 · No verified English name | Liao Yuan Shi Yin Ying Pharmaceutical Co., Ltd. romanized | Y20210000273 | A | Exact ingredient | 2026/07/28 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Liao Yuan Pharma Co., Ltd. romanized | Y20210000103 | A | Exact ingredient | 2023/05/05 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20200000494 | A | Exact ingredient | 2022/08/03 | CDE |
| 盐酸莫西沙星 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20190009766 | A | Exact ingredient | 2026/09/08 | CDE |
| 盐酸莫西沙星 · No verified English name | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Y20190006998 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Rui Yang Pharmaceutical Co., Ltd. romanized | Y20190000968 | A | Exact ingredient | 2026/06/18 | CDE |
| 盐酸莫西沙星 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20190000446 | A | Exact ingredient | 2026/09/08 | CDE |
| 盐酸莫西沙星 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20190000466 | A | Exact ingredient | 2025/09/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Xin He Cheng Co., Ltd. romanized | Y20190000343 | A | Exact ingredient | 2025/07/23 | CDE |
| 盐酸莫西沙星 · No verified English name | Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized | Y20190000161 | I | Exact ingredient | 2019/04/01 | CDE |
| 盐酸莫西沙星 · No verified English name | Hunan Dong Ting Pharma Co., Ltd. romanized | Y20180001456 | I | Exact ingredient | 2019/01/08 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20180001255 | A | Exact ingredient | 2025/11/27 | CDE |
| 盐酸莫西沙星 · No verified English name | Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | Y20180001088 | A | Exact ingredient | 2026/04/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Jiangsu Yong Da Pharma Co., Ltd. romanized | Y20180000618 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Gui Lin Nan Yao Co., Ltd. romanized | Y20170002212 | A | Exact ingredient | 2025/11/15 | CDE |
| 盐酸莫西沙星 · No verified English name | Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20170001688 | A | Exact ingredient | 2026/06/23 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20170001678 | A | Exact ingredient | 2025/12/27 | CDE |
| 盐酸莫西沙星 · No verified English name | Nanjing Sheng He Pharma Co., Ltd. romanized | Y20170001585 | A | Exact ingredient | 2024/06/06 | CDE |
| 盐酸莫西沙星 · No verified English name | Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | Y20170001536 | A | Exact ingredient | 2022/10/20 | CDE |
| 盐酸莫西沙星 · No verified English name | MSN Pharmachem Private Limited | Y20170001468 | A | Exact ingredient | 2025/12/09 | CDE |
| 盐酸莫西沙星 · No verified English name | Bei Da Pharmaceuticals Co., Ltd. romanized | Y20170001426 | A | Exact ingredient | 2024/08/27 | CDE |
| 盐酸莫西沙星 · No verified English name | Dr.Reddy's Laboratories Ltd. | Y20170001362 | A | Exact ingredient | 2023/04/02 | CDE |
| 盐酸莫西沙星 · No verified English name | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized | Y20170001344 | I | Exact ingredient | 2019/05/28 | CDE |
| 盐酸莫西沙星 · No verified English name | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20170001318 | A | Exact ingredient | 2026/09/18 | CDE |
| 盐酸莫西沙星 · No verified English name | Shenyang Zhong Hai Pharma Co., Ltd. romanized | Y20170001311 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Chongqing Qing Yang Pharma Co., Ltd. romanized | Y20170001287 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Shanxi Tong Da Pharma Co., Ltd. romanized | Y20170001220 | A | Exact ingredient | 2022/10/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Hetero Drugs Limited | Y20170001086 | A | Exact ingredient | 2025/11/21 | CDE |
| 盐酸莫西沙星 · No verified English name | Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | Y20170001062 | A | Exact ingredient | 2025/07/28 | CDE |
| 盐酸莫西沙星 · No verified English name | Sichuan Xie Li Pharmaceutical Co., Ltd. romanized | Y20170001005 | A | Exact ingredient | 2024/02/08 | CDE |
| 盐酸莫西沙星 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170000961 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized | Y20170000940 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Shaanxi Da Sheng Pharmaceutical Technology Co., Ltd. romanized | Y20170000927 | A | Exact ingredient | 2024/02/08 | CDE |
| 盐酸莫西沙星 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20170000871 | A | Exact ingredient | 2025/09/16 | CDE |
| 盐酸莫西沙星 · No verified English name | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Y20170000820 | A | Exact ingredient | 2023/09/14 | CDE |
| 盐酸莫西沙星 · No verified English name | Da Tong Chang Xing Pharmaceutical Co., Ltd. romanized | Y20170000811 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | Y20170000806 | A | Exact ingredient | 2025/03/20 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20170000798 | A | Exact ingredient | 2025/07/19 | CDE |
| 盐酸莫西沙星 · No verified English name | Zhejiang Xin He Cheng Co., Ltd. romanized | Y20170000789 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Chengdu Tong De Pharma Co., Ltd. romanized | Y20170000786 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸莫西沙星 · No verified English name | Shandong Qidu Pharmaceutical Co., Ltd. | Y20170000737 | A | Exact ingredient | 2024/01/12 | CDE |
| 盐酸莫西沙星 · No verified English name | Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | Y20170000704 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20170000682 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸莫西沙星 · No verified English name | Liaoning Ben Yuan Pharmaceutical Co., Ltd. romanized | Y20170000663 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20170000640 | A | Exact ingredient | 2026/04/30 | CDE |
| 盐酸莫西沙星 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20170000595 | A | Exact ingredient | 2026/08/22 | CDE |
| 盐酸莫西沙星 · No verified English name | Jiangsu Su Zhong Pharma Group Co., Ltd. romanized | Y20170000575 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Tianjin Hong Ri Pharma Co., Ltd. romanized | Y20170000298 | A | Exact ingredient | 2024/11/26 | CDE |
| 盐酸莫西沙星 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20170000255 | A | Exact ingredient | 2026/03/03 | CDE |
| 盐酸莫西沙星 · No verified English name | Guo Yao Group Yi Bin Pharmaceutical Co., Ltd. romanized | Y20170000071 | I | Exact ingredient | — | CDE |
| 盐酸莫西沙星 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20170000034 | A | Exact ingredient | 2025/12/31 | CDE |
| 盐酸莫西沙星 · No verified English name | Shaanxi Tai Bai Shan Pharmaceutical Co., Ltd. romanized | Y20170000024 | A | Exact ingredient | 2022/10/21 | CDE |
| 盐酸莫西沙星 · No verified English name | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20170000007 | A | Exact ingredient | 2024/04/19 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
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.
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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