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Moxifloxacin Hydrochloride Tablets

As 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

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage 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.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Xin Tian Di Pharma Co., Ltd. romanizedXu Chang Wei Lai Pharmaceutical Co., Ltd. romanized国药准字H202643032026/05/12See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanizedLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized国药准字H202642332026/05/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H202637892026/03/31See sourceGeneric approved under the new chemical-drug registration classificationCDE
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanizedHaerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H202560802025/11/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Di Fei Te Pharma Co., Ltd. romanizedJilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H202550812025/07/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanizedZhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H202546892025/06/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shanxi De Yuan Tang Pharma Co., Ltd. romanizedShanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202531452025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hebei Tian Cheng Pharma Co., Ltd. romanizedHebei Tian Cheng Pharma Co., Ltd. romanized国药准字H202531042025/01/08See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shandong Lukang Pharmaceutical Co.,Ltd.Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H202446342024/08/05See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H202440792024/06/18See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Yong Tai Pharma Co., Ltd. romanizedZhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H202440772024/06/18See sourceGeneric approved under the new chemical-drug registration classificationCDE
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H202335772023/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202230062022/01/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Gui Lin Nan Yao Co., Ltd. romanizedGui Lin Nan Yao Co., Ltd. romanized国药准字H202138512021/11/03See sourceGeneric approved under the new chemical-drug registration classificationCDE
Rui Yang Pharmaceutical Co., Ltd. romanizedRui Yang Pharmaceutical Co., Ltd. romanized国药准字H202136092021/07/28See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanizedYang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized国药准字H202135532021/06/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hunan Di Nuo Pharmaceutical Co., Ltd. romanizedHunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H202135002021/06/16See sourceGeneric approved under the new chemical-drug registration classificationCDE
HEXAL AGS.C. Sandoz S.R.L.国药准字HJ202100322021/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanizedJiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized国药准字H202133232021/04/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Kelun Pharmaceutical Co., Ltd.Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H202035162020/10/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanizedHunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized国药准字H202034332020/08/17See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shenzhen Xin Li Tai Pharma Co., Ltd. romanizedShenzhen Xin Li Tai Pharma Co., Ltd. romanized国药准字H202030622020/02/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Sheng He Pharma Co., Ltd. romanizedNanjing Sheng He Pharma Co., Ltd. romanized国药准字H201934322019/12/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Name not romanizedChongqing Huapont Pharmaceutical Co., Ltd.国药准字H201934062019/12/26See sourceGeneric approved under the new chemical-drug registration classificationCDE
Name not romanizedNanjing You Ke Pharmaceutical Co., Ltd. romanized国药准字H201933872019/12/18See sourceGeneric approved under the new chemical-drug registration classificationCDE
Beijing Foyou Pharma CO.,LTDBeijing Foyou Pharma CO.,LTD国药准字H201830962019/12/17See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Sichuan Gowell Pharmaceutical Co., Ltd.Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H201835302018/12/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanizedGuangdong Dong Yang Guang Pharma Co., Ltd. romanized国药准字H201832462018/07/06See sourceGeneric approved under the new chemical-drug registration classificationCDE
Bayer Vital GmbHBayer Pharma AGH20140721;H20140722;H201407232002/08/300.4gImported originator drugCDE

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

NHSA drug codes

Loaded records: 32 distinct approval numbers and 29 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Bayer Vital GmbH国药准字J201500150.4gCategory BXJ01MAM122A001010100002NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20183096See sourceCategory BXJ01MAM122A001010100177NHSA
Shenzhen Xin Li Tai Pharma Co., Ltd. romanized国药准字H20203062See sourceCategory BXJ01MAM122A001010100553NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010100601NHSA
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20193406See sourceCategory BXJ01MAM122A001010101003NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010101467NHSA
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20193432See sourceCategory BXJ01MAM122A001010101583NHSA
Sichuan Di Fei Te Pharma Co., Ltd. romanized国药准字H20255081See sourceCategory BXJ01MAM122A001010102064NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203516See sourceCategory BXJ01MAM122A001010102180NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010102662NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20223006See sourceCategory BXJ01MAM122A001010102763NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010102877NHSA
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H20256080See sourceCategory BXJ01MAM122A001010103783NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010104127NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20213609See sourceCategory BXJ01MAM122A001010104152NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20233577See sourceCategory BXJ01MAM122A001010104565NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20213367See sourceCategory BXJ01MAM122A001010104641NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010104914NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H20213851See sourceCategory BXJ01MAM122A001010105206NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20183246See sourceCategory BXJ01MAM122A001010106988NHSA
Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized国药准字H20203433See sourceCategory BXJ01MAM122A001010109604NHSA
Bayer Vital GmbH国药准字HJ201407210.4gCategory BXJ01MAM122A001010178271NHSA
Nanjing You Ke Pharmaceutical Co., Ltd. romanized国药准字H20193387See sourceCategory BXJ01MAM122A001010180542NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001010180937NHSA
Zhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H20244077See sourceCategory BXJ01MAM122A001010181012NHSA
Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized国药准字H20213553See sourceCategory BXJ01MAM122A001010182147NHSA
Xin Tian Di Pharma Co., Ltd. romanized国药准字H20264303See sourceCategory BXJ01MAM122A001010182462NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244634See sourceCategory BXJ01MAM122A001010183198NHSA
Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized国药准字H20264233See sourceCategory BXJ01MAM122A001010183546NHSA
Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized国药准字H20213323See sourceCategory BXJ01MAM122A001010183586NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20183096See sourceCategory BXJ01MAM122A001010200177NHSA
Shenzhen Xin Li Tai Pharma Co., Ltd. romanized国药准字H20203062See sourceCategory BXJ01MAM122A001010200553NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010200601NHSA
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20193406See sourceCategory BXJ01MAM122A001010201003NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010201467NHSA
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20193432See sourceCategory BXJ01MAM122A001010201583NHSA
Sichuan Di Fei Te Pharma Co., Ltd. romanized国药准字H20255081See sourceCategory BXJ01MAM122A001010202064NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20203516See sourceCategory BXJ01MAM122A001010202180NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010202662NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20223006See sourceCategory BXJ01MAM122A001010202763NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010202877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010204127NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20213609See sourceCategory BXJ01MAM122A001010204152NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20233577See sourceCategory BXJ01MAM122A001010204565NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20213367See sourceCategory BXJ01MAM122A001010204641NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010204914NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H20213851See sourceCategory BXJ01MAM122A001010205206NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20183246See sourceCategory BXJ01MAM122A001010206988NHSA
Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized国药准字H20203433See sourceCategory BXJ01MAM122A001010209604NHSA
Bayer Vital GmbH国药准字HJ201407220.4gCategory BXJ01MAM122A001010278271NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001010280937NHSA
Zhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H20244077See sourceCategory BXJ01MAM122A001010281012NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244634See sourceCategory BXJ01MAM122A001010283198NHSA
Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized国药准字H20264233See sourceCategory BXJ01MAM122A001010283546NHSA
Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized国药准字H20213323See sourceCategory BXJ01MAM122A001010283586NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20183096See sourceCategory BXJ01MAM122A001010300177NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010300601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010301467NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010302662NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20223006See sourceCategory BXJ01MAM122A001010302763NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010302877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010304127NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20233577See sourceCategory BXJ01MAM122A001010304565NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20213367See sourceCategory BXJ01MAM122A001010304641NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010304914NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H20213851See sourceCategory BXJ01MAM122A001010305206NHSA
Bayer Vital GmbH国药准字HJ201407220.4gCategory BXJ01MAM122A001010378271NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001010380937NHSA
Zhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H20244077See sourceCategory BXJ01MAM122A001010381012NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20183096See sourceCategory BXJ01MAM122A001010400177NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010400601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010401467NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010402662NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010402877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010404127NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20233577See sourceCategory BXJ01MAM122A001010404565NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20213367See sourceCategory BXJ01MAM122A001010404641NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010404914NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H20213851See sourceCategory BXJ01MAM122A001010405206NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20183096See sourceCategory BXJ01MAM122A001010500177NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010500601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010501467NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010502662NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010502877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010504127NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20233577See sourceCategory BXJ01MAM122A001010504565NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20213367See sourceCategory BXJ01MAM122A001010504641NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010504914NHSA
Bayer Vital GmbH国药准字HJ201407230.4gCategory BXJ01MAM122A001010578271NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20183096See sourceCategory BXJ01MAM122A001010600177NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010600601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010601467NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010602662NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010602877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010604127NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20213367See sourceCategory BXJ01MAM122A001010604641NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010604914NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010700601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010701467NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010702662NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010702877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010704127NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010704914NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010800601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010801467NHSA
Hebei Tian Cheng Pharma Co., Ltd. romanized国药准字H20253104See sourceCategory BXJ01MAM122A001010802662NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010802877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010804127NHSA
Hunan Di Nuo Pharmaceutical Co., Ltd. romanized国药准字H20213500See sourceCategory BXJ01MAM122A001010804914NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001010900601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001010901467NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H20253145See sourceCategory BXJ01MAM122A001010902877NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001010904127NHSA
Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized国药准字H20254689See sourceCategory BXJ01MAM122A001011000601NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001011001467NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001011004127NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001011101467NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001011104127NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H20244079See sourceCategory BXJ01MAM122A001011201467NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001011204127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001011304127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001011404127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20263789See sourceCategory BXJ01MAM122A001011504127NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20183246See sourceCategory BXJ01MAM122A001020106988NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001020180937NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244634See sourceCategory BXJ01MAM122A001020183198NHSA
Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized国药准字H20213323See sourceCategory BXJ01MAM122A001020183586NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001020280937NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244634See sourceCategory BXJ01MAM122A001020283198NHSA
Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized国药准字H20213323See sourceCategory BXJ01MAM122A001020283586NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001020380937NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244634See sourceCategory BXJ01MAM122A001020383198NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001020480937NHSA
Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H20183530See sourceCategory BXJ01MAM122A001020580937NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20183246See sourceCategory BXJ01MAM122A001030106988NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20183246See sourceCategory BXJ01MAM122A001040106988NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 11 filings and 8 distinct first applicants.

Supplement 5 · Generic 6

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l.JYHB2600455Supplement2026/08/12Not stated by sourceCDE
Sichuan Gowell Pharmaceutical Co., Ltd.CYHB2600779Supplement2026/04/18Not stated by sourceCDE
Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanizedCYHS2600411Generic2026/02/09Not stated by sourceCDE
Bei Da Pharmaceuticals Co., Ltd. romanizedCYHS2600143Generic2026/01/12Not stated by sourceCDE
Jiangxi Hong Shuo Pharmaceutical Co., Ltd. romanizedCYHS2504102Generic2025/11/28Not stated by sourceCDE
Zhengzhou Han Dou Pharma Group Co., Ltd. romanizedCYHS2503969Generic2025/11/15Not stated by sourceCDE
Jilin Dao Jun Pharma Co., Ltd. romanizedCYHS2503917Generic2025/11/11Not stated by sourceCDE
Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l.; Name not romanizedJYHB2500581Supplement2025/10/31Not stated by sourceCDE
Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l.JYHB2500580Supplement2025/10/31Not stated by sourceCDE
Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l.JYHB2500579Supplement2025/10/31Not stated by sourceCDE
Hainan Hai Li Pharmaceutical Co., Ltd. romanizedCYHS2501805Generic2025/05/17Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanizedCYHS2600411Generic2026/02/09Not stated by sourceCDE
Bei Da Pharmaceuticals Co., Ltd. romanizedCYHS2600143Generic2026/01/12Not stated by sourceCDE
API registrations

Non-component matches: 48 companies with A status and 16 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸莫西沙星 · No verified English nameJiangxi Shan Yuan Pharma Co., Ltd. romanizedY20260000402IExact ingredient2026/09/17CDE
盐酸莫西沙星 · No verified English nameJiangxi Xiang Tai Sheng Ming Ke Xue Co., Ltd. romanizedY20240000879IExact ingredient2024/08/23CDE
盐酸莫西沙星 · No verified English nameLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY20230001071AExact ingredient2025/07/22CDE
盐酸莫西沙星 · No verified English nameZhejiang Xin He Cheng Co., Ltd. romanizedY20230000900AExact ingredient2026/03/31CDE
盐酸莫西沙星 · No verified English nameHebei Tian Cheng Pharma Co., Ltd. romanizedY20220000887AExact ingredient2024/07/09CDE
盐酸莫西沙星 · No verified English nameHebei Kai Wei Kang Ling Pharmaceutical Co., Ltd. romanizedY20220000860AExact ingredient2024/12/04CDE
盐酸莫西沙星 · No verified English nameShandong Lukang Pharmaceutical Co.,Ltd.Y20220000493AExact ingredient2025/12/24CDE
盐酸莫西沙星 · No verified English nameXian Wan Long Pharmaceutical Co., Ltd. romanizedY20220000473IExact ingredient2022/07/05CDE
盐酸莫西沙星 · No verified English nameYi Chang Dong Yang Guang Pharmaceutical Co., Ltd. romanizedY20220000196AExact ingredient2025/09/06CDE
盐酸莫西沙星 · No verified English nameHeilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanizedY20220000100AExact ingredient2025/06/07CDE
盐酸莫西沙星 · No verified English nameChangzhou Hong Tai Yang Pharma Co., Ltd. romanizedY20210001254AExact ingredient2024/04/28CDE
盐酸莫西沙星 · No verified English nameChongqing Shi Nan An Qu Jiang Qiao Lu 8 Hao romanizedY20210001098AExact ingredient2026/07/16CDE
盐酸莫西沙星 · No verified English nameXin Tian Di Pharma Co., Ltd. romanizedY20210000980AExact ingredient2026/02/27CDE
盐酸莫西沙星 · No verified English nameAnhui Jian Feng Bei Ka Pharma Co., Ltd. romanizedY20210000527AExact ingredient2025/12/23CDE
盐酸莫西沙星 · No verified English nameLiao Yuan Shi Yin Ying Pharmaceutical Co., Ltd. romanizedY20210000273AExact ingredient2026/07/28CDE
盐酸莫西沙星 · No verified English nameZhejiang Liao Yuan Pharma Co., Ltd. romanizedY20210000103AExact ingredient2023/05/05CDE
盐酸莫西沙星 · No verified English nameZhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY20200000494AExact ingredient2022/08/03CDE
盐酸莫西沙星 · No verified English nameSichuan Gowell Pharmaceutical Co., Ltd.Y20190009766AExact ingredient2026/09/08CDE
盐酸莫西沙星 · No verified English nameNanjing You Ke Pharmaceutical Co., Ltd. romanizedY20190006998AExact ingredient2023/03/24CDE
盐酸莫西沙星 · No verified English nameRui Yang Pharmaceutical Co., Ltd. romanizedY20190000968AExact ingredient2026/06/18CDE
盐酸莫西沙星 · No verified English nameSichuan Gowell Pharmaceutical Co., Ltd.Y20190000446AExact ingredient2026/09/08CDE
盐酸莫西沙星 · No verified English nameBeijing Foyou Pharma CO.,LTDY20190000466AExact ingredient2025/09/24CDE
盐酸莫西沙星 · No verified English nameZhejiang Xin He Cheng Co., Ltd. romanizedY20190000343AExact ingredient2025/07/23CDE
盐酸莫西沙星 · No verified English nameWuhan Wu Yao Pharmaceutical Co., Ltd. romanizedY20190000161IExact ingredient2019/04/01CDE
盐酸莫西沙星 · No verified English nameHunan Dong Ting Pharma Co., Ltd. romanizedY20180001456IExact ingredient2019/01/08CDE
盐酸莫西沙星 · No verified English nameZhejiang Guo Bang Pharma Co., Ltd. romanizedY20180001255AExact ingredient2025/11/27CDE
盐酸莫西沙星 · No verified English nameJiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanizedY20180001088AExact ingredient2026/04/24CDE
盐酸莫西沙星 · No verified English nameJiangsu Yong Da Pharma Co., Ltd. romanizedY20180000618IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameGui Lin Nan Yao Co., Ltd. romanizedY20170002212AExact ingredient2025/11/15CDE
盐酸莫西沙星 · No verified English nameSichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY20170001688AExact ingredient2026/06/23CDE
盐酸莫西沙星 · No verified English nameZhejiang Hai Zheng Pharma Co., Ltd. romanizedY20170001678AExact ingredient2025/12/27CDE
盐酸莫西沙星 · No verified English nameNanjing Sheng He Pharma Co., Ltd. romanizedY20170001585AExact ingredient2024/06/06CDE
盐酸莫西沙星 · No verified English nameHunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanizedY20170001536AExact ingredient2022/10/20CDE
盐酸莫西沙星 · No verified English nameMSN Pharmachem Private LimitedY20170001468AExact ingredient2025/12/09CDE
盐酸莫西沙星 · No verified English nameBei Da Pharmaceuticals Co., Ltd. romanizedY20170001426AExact ingredient2024/08/27CDE
盐酸莫西沙星 · No verified English nameDr.Reddy's Laboratories Ltd.Y20170001362AExact ingredient2023/04/02CDE
盐酸莫西沙星 · No verified English nameXiamen En Cheng Pharmaceutical Co., Ltd. romanizedY20170001344IExact ingredient2019/05/28CDE
盐酸莫西沙星 · No verified English nameShanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanizedY20170001318AExact ingredient2026/09/18CDE
盐酸莫西沙星 · No verified English nameShenyang Zhong Hai Pharma Co., Ltd. romanizedY20170001311IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameChongqing Qing Yang Pharma Co., Ltd. romanizedY20170001287IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameShanxi Tong Da Pharma Co., Ltd. romanizedY20170001220AExact ingredient2022/10/24CDE
盐酸莫西沙星 · No verified English nameHetero Drugs LimitedY20170001086AExact ingredient2025/11/21CDE
盐酸莫西沙星 · No verified English nameHunan Di Nuo Pharmaceutical Co., Ltd. romanizedY20170001062AExact ingredient2025/07/28CDE
盐酸莫西沙星 · No verified English nameSichuan Xie Li Pharmaceutical Co., Ltd. romanizedY20170001005AExact ingredient2024/02/08CDE
盐酸莫西沙星 · No verified English nameSHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDY20170000961IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameKunming Yuan Rui Pharmaceutical Co., Ltd. romanizedY20170000940IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameShaanxi Da Sheng Pharmaceutical Technology Co., Ltd. romanizedY20170000927AExact ingredient2024/02/08CDE
盐酸莫西沙星 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20170000871AExact ingredient2025/09/16CDE
盐酸莫西沙星 · No verified English nameShenzhen Xin Li Tai Pharma Co., Ltd. romanizedY20170000820AExact ingredient2023/09/14CDE
盐酸莫西沙星 · No verified English nameDa Tong Chang Xing Pharmaceutical Co., Ltd. romanizedY20170000811IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameJiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanizedY20170000806AExact ingredient2025/03/20CDE
盐酸莫西沙星 · No verified English nameZhuhai Run Dou Pharmaceutical Co., Ltd. romanizedY20170000798AExact ingredient2025/07/19CDE
盐酸莫西沙星 · No verified English nameZhejiang Xin He Cheng Co., Ltd. romanizedY20170000789AExact ingredient2023/03/24CDE
盐酸莫西沙星 · No verified English nameChengdu Tong De Pharma Co., Ltd. romanizedY20170000786AExact ingredient2023/03/24CDE
盐酸莫西沙星 · No verified English nameShandong Qidu Pharmaceutical Co., Ltd.Y20170000737AExact ingredient2024/01/12CDE
盐酸莫西沙星 · No verified English nameJiangsu Yun Yang Group Pharma Co., Ltd. romanizedY20170000704IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameYi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedY20170000682AExact ingredient2024/01/17CDE
盐酸莫西沙星 · No verified English nameLiaoning Ben Yuan Pharmaceutical Co., Ltd. romanizedY20170000663IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20170000640AExact ingredient2026/04/30CDE
盐酸莫西沙星 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20170000595AExact ingredient2026/08/22CDE
盐酸莫西沙星 · No verified English nameJiangsu Su Zhong Pharma Group Co., Ltd. romanizedY20170000575IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameTianjin Hong Ri Pharma Co., Ltd. romanizedY20170000298AExact ingredient2024/11/26CDE
盐酸莫西沙星 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20170000255AExact ingredient2026/03/03CDE
盐酸莫西沙星 · No verified English nameGuo Yao Group Yi Bin Pharmaceutical Co., Ltd. romanizedY20170000071IExact ingredient—CDE
盐酸莫西沙星 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20170000034AExact ingredient2025/12/31CDE
盐酸莫西沙星 · No verified English nameShaanxi Tai Bai Shan Pharmaceutical Co., Ltd. romanizedY20170000024AExact ingredient2022/10/21CDE
盐酸莫西沙星 · No verified English nameLian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY20170000007AExact ingredient2024/04/19CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 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.

  1. No matching records were found in the currently loaded source data; coverage dates are listed below.

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.

NMPA drug delivery notices
Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete

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.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

Public-product searches scanned: 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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