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Public drug landscapesDrug landscape

Levofloxacin Eye Drops

As of 13 November 2026, for Levofloxacin Eye Drops, 16 applications are listed as under review at China's CDE; 8 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

Companies, stages and changes, with each record available on this page.

Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applications

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: Eye Drops. 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
QUIXIN SANTEN INC NDA 021199 · Product no. 001 SOLUTION/DROPS OPHTHALMIC DISCONTINUED 2000/08/18
IQUIX SANTEN INC NDA 021571 · Product no. 001 SOLUTION/DROPS OPHTHALMIC DISCONTINUED 2004/03/01

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
LEVAQUIN JANSSEN PHARMACEUTICALS INC NDA 020634 · Product no. 001, 002 TABLET ORAL DISCONTINUED 1996/12/20
LEVAQUIN JANSSEN PHARMACEUTICALS INC NDA 020635 · Product no. 001, 004 INJECTABLE INJECTION DISCONTINUED 1996/12/20
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER JANSSEN PHARMACEUTICALS INC NDA 020635 · Product no. 002, 003, 005 INJECTABLE INJECTION DISCONTINUED 1996/12/20
LEVAQUIN JANSSEN PHARMACEUTICALS INC NDA 020634 · Product no. 003 TABLET ORAL DISCONTINUED 2000/09/08
LEVAQUIN JANSSEN PHARMACEUTICALS INC NDA 021721 · Product no. 001 SOLUTION ORAL DISCONTINUED 2004/10/21

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: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Santen Pharmaceutical Co.,Ltd.Santen Pharmaceutical Co., Ltd. Ying Gai Wei Santen Pharmaceutical Co., Ltd. Noto Plant romanizedH201502782004/11/155ml:24.4mgImported 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: 55 distinct approval numbers and 47 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangdong Nan Guo Pharma Co., Ltd. romanized国药准字H20264249See sourceCategory AXS01AEZ074G010010100315NHSA
Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized国药准字H20234675See sourceCategory AXS01AEZ074G010010100547NHSA
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized国药准字H20233723See sourceCategory AXS01AEZ074G010010100548NHSA
Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized国药准字H20183227See sourceCategory AXS01AEZ074G010010100612NHSA
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H20203593See sourceCategory AXS01AEZ074G010010101322NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20103148See sourceCategory AXS01AEZ074G010010101442NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20253857See sourceCategory AXS01AEZ074G010010101503NHSA
Suzhou Hong Sen Pharma Co., Ltd. romanized国药准字H20243939See sourceCategory AXS01AEZ074G010010101518NHSA
Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized国药准字H20173405See sourceCategory AXS01AEZ074G010010101652NHSA
Yangtze River Pharmaceutical Group Co., Ltd国药准字H20203092See sourceCategory AXS01AEZ074G010010101749NHSA
Wuhan Nuo An Pharma Co., Ltd. romanized国药准字H20183382See sourceCategory AXS01AEZ074G010010101955NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249743See sourceCategory AXS01AEZ074G010010101967NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H20203457See sourceCategory AXS01AEZ074G010010102087NHSA
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H20093808See sourceCategory AXS01AEZ074G010010102138NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20113118See sourceCategory AXS01AEZ074G010010102680NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20233998See sourceCategory AXS01AEZ074G010010102733NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20256148See sourceCategory AXS01AEZ074G010010102763NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H20244930See sourceCategory AXS01AEZ074G010010103358NHSA
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H20254737See sourceCategory AXS01AEZ074G010010103454NHSA
Anhui Huan Qiu Pharma Co., Ltd. romanized国药准字H20243616See sourceCategory AXS01AEZ074G010010104303NHSA
Hefei Li Min Pharmaceutical Co., Ltd. romanized国药准字H20254640See sourceCategory AXS01AEZ074G010010104423NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010104693NHSA
Fujian Tian Quan Pharma Co., Ltd. romanized国药准字H20265172See sourceCategory AXS01AEZ074G010010104817NHSA
Yunnan Dai Yao Co., Ltd. romanized国药准字H20244929See sourceCategory AXS01AEZ074G010010105619NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20263023See sourceCategory AXS01AEZ074G010010105816NHSA
Santen Pharmaceutical Co.,Ltd.国药准字J201501065ml:24.4mgCategory AXS01AEZ074G010010109591NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20203122See sourceCategory AXS01AEZ074G010010109920NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H20254733See sourceCategory AXS01AEZ074G010010110144NHSA
Shandong Guang Ming Pharma Co., Ltd. romanized国药准字H20243581See sourceCategory AXS01AEZ074G010010180494NHSA
Sichuan He Yi Pharmaceutical Co., Ltd. romanized国药准字H20203500See sourceCategory AXS01AEZ074G010010181567NHSA
Shenzhen Shi Rui Lin Pharmaceuticals Co., Ltd. romanized国药准字H20213721See sourceCategory AXS01AEZ074G010010183060NHSA
Shijiazhuang Kai Sai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249227See sourceCategory AXS01AEZ074G010010183164NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H20254169See sourceCategory AXS01AEZ074G010010183191NHSA
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized国药准字H20223131See sourceCategory AXS01AEZ074G010010183223NHSA
Ai Shi Pharmaceutical Co., Ltd. romanized国药准字H20234223See sourceCategory AXS01AEZ074G010010183549NHSA
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H20244928See sourceCategory AXS01AEZ074G010010183562NHSA
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249567See sourceCategory AXS01AEZ074G010010184738NHSA
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized国药准字H20263115See sourceCategory AXS01AEZ074G010010184784NHSA
Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263582See sourceCategory AXS01AEZ074G010010185039NHSA
Anhui Kang Rong Pharma Co., Ltd. romanized国药准字H20264702See sourceCategory AXS01AEZ074G010010185072NHSA
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized国药准字H20233723See sourceCategory AXS01AEZ074G010010200548NHSA
Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized国药准字H20183227See sourceCategory AXS01AEZ074G010010200612NHSA
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H20203593See sourceCategory AXS01AEZ074G010010201322NHSA
Suzhou Hong Sen Pharma Co., Ltd. romanized国药准字H20243939See sourceCategory AXS01AEZ074G010010201518NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249743See sourceCategory AXS01AEZ074G010010201967NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20233998See sourceCategory AXS01AEZ074G010010202733NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H20244930See sourceCategory AXS01AEZ074G010010203358NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010204693NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20263023See sourceCategory AXS01AEZ074G010010205816NHSA
Santen Pharmaceutical Co.,Ltd.国药准字HJ20150278See sourceCategory AXS01AEZ074G010010278986NHSA
Shandong Guang Ming Pharma Co., Ltd. romanized国药准字H20243581See sourceCategory AXS01AEZ074G010010280494NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H20254169See sourceCategory AXS01AEZ074G010010283191NHSA
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249567See sourceCategory AXS01AEZ074G010010284738NHSA
Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized国药准字H20183227See sourceCategory AXS01AEZ074G010010300612NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249743See sourceCategory AXS01AEZ074G010010301967NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H20244930See sourceCategory AXS01AEZ074G010010303358NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010304693NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20263023See sourceCategory AXS01AEZ074G010010305816NHSA
Santen Pharmaceutical Co.,Ltd.国药准字HJ20150278See sourceCategory AXS01AEZ074G010010378986NHSA
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249567See sourceCategory AXS01AEZ074G010010384738NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H20244930See sourceCategory AXS01AEZ074G010010403358NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010404693NHSA
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249567See sourceCategory AXS01AEZ074G010010484738NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010504693NHSA
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249567See sourceCategory AXS01AEZ074G010010584738NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010604693NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010704693NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20234661See sourceCategory AXS01AEZ074G010010804693NHSA
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H20217093See sourceCategory AXS01AEZ074G010020101322NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20103148See sourceCategory AXS01AEZ074G010020101442NHSA
Suzhou Hong Sen Pharma Co., Ltd. romanized国药准字H20243939See sourceCategory AXS01AEZ074G010020101518NHSA
Wuhan Nuo An Pharma Co., Ltd. romanized国药准字H20223058See sourceCategory AXS01AEZ074G010020101955NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20113118See sourceCategory AXS01AEZ074G010020102680NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20247322See sourceCategory AXS01AEZ074G010020102733NHSA
Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized国药准字H20205052See sourceCategory AXS01AEZ074G010020109591NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20203122See sourceCategory AXS01AEZ074G010020109920NHSA
Sichuan He Yi Pharmaceutical Co., Ltd. romanized国药准字H20217124See sourceCategory AXS01AEZ074G010020181567NHSA
Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized国药准字H20223033See sourceCategory AXS01AEZ074G010020183060NHSA
Ai Shi Pharmaceutical Co., Ltd. romanized国药准字H20234222See sourceCategory AXS01AEZ074G010020183549NHSA
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H20249151See sourceCategory AXS01AEZ074G010020183562NHSA
Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263582See sourceCategory AXS01AEZ074G010020185039NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20247322See sourceCategory AXS01AEZ074G010020202733NHSA
Sichuan He Yi Pharmaceutical Co., Ltd. romanized国药准字H20217124See sourceCategory AXS01AEZ074G010020281567NHSA
Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized国药准字H20223033See sourceCategory AXS01AEZ074G010020283060NHSA
Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263582See sourceCategory AXS01AEZ074G010020285039NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20247322See sourceCategory AXS01AEZ074G010020302733NHSA
Sichuan He Yi Pharmaceutical Co., Ltd. romanized国药准字H20217124See sourceCategory AXS01AEZ074G010020381567NHSA
Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized国药准字H20223033See sourceCategory AXS01AEZ074G010020383060NHSA
Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263582See sourceCategory AXS01AEZ074G010020385039NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20247322See sourceCategory AXS01AEZ074G010020402733NHSA
Sichuan He Yi Pharmaceutical Co., Ltd. romanized国药准字H20217124See sourceCategory AXS01AEZ074G010020481567NHSA
Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized国药准字H20223033See sourceCategory AXS01AEZ074G010020483060NHSA
Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263582See sourceCategory AXS01AEZ074G010020485039NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20247322See sourceCategory AXS01AEZ074G010020502733NHSA
Sichuan He Yi Pharmaceutical Co., Ltd. romanized国药准字H20217124See sourceCategory AXS01AEZ074G010020581567NHSA
Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized国药准字H20223033See sourceCategory AXS01AEZ074G010020583060NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20247322See sourceCategory AXS01AEZ074G010020602733NHSA
Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized国药准字H20223033See sourceCategory AXS01AEZ074G010020683060NHSA
Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized国药准字H20256135See sourceCategory AXS01AEZ074G010030100600NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20103148See sourceCategory AXS01AEZ074G010030101442NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20233516See sourceCategory AXS01AEZ074G010030102298NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20113118See sourceCategory AXS01AEZ074G010030102680NHSA
Ningxia Kang Ya Pharma Co., Ltd. romanized国药准字H20223509See sourceCategory AXS01AEZ074G010030105911NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20203122See sourceCategory AXS01AEZ074G010030109920NHSA
Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263582See sourceCategory AXS01AEZ074G010030185039NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20233516See sourceCategory AXS01AEZ074G010030202298NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20233516See sourceCategory AXS01AEZ074G010030302298NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20233516See sourceCategory AXS01AEZ074G010030402298NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20233516See sourceCategory AXS01AEZ074G010030502298NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20103148See sourceCategory AXS01AEZ074G010040101442NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20113118See sourceCategory AXS01AEZ074G010040102680NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20247102See sourceCategory AXS01AEZ074G010040109920NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20247102See sourceCategory AXS01AEZ074G010040209920NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20247102See sourceCategory AXS01AEZ074G010040309920NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20247102See sourceCategory AXS01AEZ074G010040409920NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20103148See sourceCategory AXS01AEZ074G010050101442NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20113118See sourceCategory AXS01AEZ074G010050102680NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20203122See sourceCategory AXS01AEZ074G010050109920NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20103148See sourceCategory AXS01AEZ074G010060101442NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20113118See sourceCategory AXS01AEZ074G010070102680NHSA
Hebei He Du Pharma Co., Ltd. romanized国药准字H20255153See sourceCategory AXS01AEZ074G010080102680NHSA
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized国药准字H20255627See sourceCategory AXS01AEZ074G010090102680NHSA

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: 16 filings and 13 distinct first applicants.

Generic 13 · Supplement 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Anhui Sheng Shuang Ke Pharma Co., Ltd. romanizedCYHS2602543Generic2026/10/14Not stated by sourceCDE
Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanizedCYHS2602399Generic2026/09/23Not stated by sourceCDE
Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanizedCYHS2601996Generic2026/08/13Not stated by sourceCDE
Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanizedCYHS2601995Generic2026/08/13Not stated by sourceCDE
Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHS2601794Generic2026/07/27Not stated by sourceCDE
Guangdong Nan Guo Pharma Co., Ltd. romanizedCYHB2601378Supplement2026/07/21Not stated by sourceCDE
Heilongjiang Xian Dong Pharma Co., Ltd. romanizedCYHS2601622Generic2026/07/07Not stated by sourceCDE
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHB2601277Supplement2026/07/07Not stated by sourceCDE
Changchun Di Rui Pharmaceutical Co., Ltd. romanizedCYHS2600681Generic2026/03/19Not stated by sourceCDE
Changchun Di Rui Pharmaceutical Co., Ltd. romanizedCYHS2600680Generic2026/03/19Not stated by sourceCDE
Changchun Di Rui Pharmaceutical Co., Ltd. romanizedCYHS2600679Generic2026/03/19Not stated by sourceCDE
Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanizedCYHS2600542Generic2026/02/26Not stated by sourceCDE
Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanizedCYHS2504524Generic2026/01/04Not stated by sourceCDE
Wuhan Wu Jing Pharma Co., Ltd. romanizedCYHS2504307Generic2025/12/17Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHB2501931Supplement2025/09/28Not stated by sourceCDE
Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanizedCYHS2502440Generic2025/07/09Not stated by sourceCDE
New generic filings in 2026

Loaded records: 11 filings and 8 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Anhui Sheng Shuang Ke Pharma Co., Ltd. romanizedCYHS2602543Generic2026/10/14Not stated by sourceCDE
Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanizedCYHS2602399Generic2026/09/23Not stated by sourceCDE
Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanizedCYHS2601996Generic2026/08/13Not stated by sourceCDE
Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanizedCYHS2601995Generic2026/08/13Not stated by sourceCDE
Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHS2601794Generic2026/07/27Not stated by sourceCDE
Heilongjiang Xian Dong Pharma Co., Ltd. romanizedCYHS2601622Generic2026/07/07Not stated by sourceCDE
Changchun Di Rui Pharmaceutical Co., Ltd. romanizedCYHS2600681Generic2026/03/19Not stated by sourceCDE
Changchun Di Rui Pharmaceutical Co., Ltd. romanizedCYHS2600680Generic2026/03/19Not stated by sourceCDE
Changchun Di Rui Pharmaceutical Co., Ltd. romanizedCYHS2600679Generic2026/03/19Not stated by sourceCDE
Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanizedCYHS2600542Generic2026/02/26Not stated by sourceCDE
Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanizedCYHS2504524Generic2026/01/04Not stated by sourceCDE
API registrations

Non-component matches: 51 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
左氧氟沙星 · No verified English nameZhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY20220001323AExact ingredient2025/09/28CDE
左氧氟沙星 · No verified English nameQUIMICA SINTETICA S.A.Y20220000523AExact ingredient2024/11/29CDE
左氧氟沙星 · No verified English nameZhejiang Si Tai Li Pharmaceutical Co., Ltd. romanizedY20190009874AExact ingredient2023/06/22CDE
盐酸左氧氟沙星 · No verified English nameZhejiang Dong Ya Pharma Co., Ltd. romanizedY20190009849ASalt-normalized ingredient2025/04/02CDE
乳酸左氧氟沙星 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20190009764ASalt-normalized ingredient2026/01/13CDE
左氧氟沙星 · No verified English nameZhejiang Dong Ya Pharma Co., Ltd. romanizedY20190009576AExact ingredient2024/12/10CDE
左氧氟沙星 · No verified English nameZhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.Y20190009507AExact ingredient2024/11/09CDE
左氧氟沙星 · No verified English nameZhejiang Lang Hua Pharmaceutical Co., Ltd. romanizedY20190009366AExact ingredient2024/10/12CDE
左氧氟沙星 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20190009344AExact ingredient2025/01/08CDE
左氧氟沙星 · No verified English nameDAIICHI SANKYO CO.,LTD.Y20190009123AExact ingredient2024/11/12CDE
左氧氟沙星 · No verified English nameDAIICHI SANKYO CO., LTD.Y20190009121AExact ingredient2024/11/12CDE
盐酸左氧氟沙星 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20190008943ASalt-normalized ingredient2024/12/27CDE
甲磺酸左氧氟沙星 · No verified English nameGuangdong Yi Shu Pharmaceutical Co., Ltd. romanizedY20190008856ASalt-normalized ingredient—CDE
盐酸左氧氟沙星 · No verified English nameHenan Kang Da Pharmaceutical Co., Ltd. romanizedY20190007638ASalt-normalized ingredient2024/07/20CDE
左氧氟沙星 · No verified English nameZhejiang AngLiKang Pharmaceutical CO.,LTD.Y20190007461AExact ingredient2024/02/05CDE
左氧氟沙星 · No verified English nameZhejiang Guo Bang Pharma Co., Ltd. romanizedY20190007451AExact ingredient2024/02/08CDE
盐酸左氧氟沙星 · No verified English nameZhejiang Guo Bang Pharma Co., Ltd. romanizedY20190007450ASalt-normalized ingredient2024/02/08CDE
甲磺酸左氧氟沙星 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20190007440ASalt-normalized ingredient2024/01/17CDE
左氧氟沙星 · No verified English nameHebei Zhi Tong Biopharmaceutical Co., Ltd. romanizedY20190007089AExact ingredient2024/03/05CDE
乳酸左氧氟沙星 · No verified English nameShanxi Pu De Pharma Co., Ltd. romanizedY20190007045ASalt-normalized ingredient2023/03/24CDE
乳酸左氧氟沙星 · No verified English nameHubei Si Huan Pharmaceutical Co., Ltd. romanizedY20190006942ASalt-normalized ingredient2023/03/24CDE
左氧氟沙星 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20190006790AExact ingredient2023/03/24CDE
乳酸左氧氟沙星 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20190006750ASalt-normalized ingredient2025/08/22CDE
甲磺酸左氧氟沙星 · No verified English nameHainan Xin Shi Tong Pharmaceutical Co., Ltd. romanizedY20190006744ASalt-normalized ingredient—CDE
盐酸左氧氟沙星 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20190006709ASalt-normalized ingredient2025/08/22CDE
乳酸左氧氟沙星 · No verified English nameLu An Hua Yuan Pharmaceutical Co., Ltd. romanizedY20190006541ASalt-normalized ingredient—CDE
甲磺酸左氧氟沙星 · No verified English nameJiang Ling Ben Da Pharmaceutical Co., Ltd. romanizedY20190006510ASalt-normalized ingredient—CDE
盐酸左氧氟沙星 · No verified English nameZhejiang Si Tai Li Pharmaceutical Co., Ltd. romanizedY20190006264ASalt-normalized ingredient2025/07/18CDE
甲磺酸左氧氟沙星 · No verified English nameZhejiang Hang Kang Pharma Co., Ltd. romanizedY20190006174ASalt-normalized ingredient—CDE
甲磺酸左氧氟沙星 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190006074ASalt-normalized ingredient2024/07/11CDE
甲磺酸左氧氟沙星 · No verified English nameHainan Ling Kang Pharmaceutical Co., Ltd. romanizedY20190006073ASalt-normalized ingredient2024/07/12CDE
甲磺酸左氧氟沙星 · No verified English nameHainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedY20190005980ASalt-normalized ingredient2025/06/11CDE
甲磺酸左氧氟沙星 · No verified English nameSichuan Bai Li Pharma Co., Ltd. romanizedY20190005950ASalt-normalized ingredient2026/01/09CDE
左氧氟沙星 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20190005279AExact ingredient2025/09/18CDE
盐酸左氧氟沙星 · No verified English nameChangzhou Lan Ling Pharmaceutical Co., Ltd. romanizedY20190004985ASalt-normalized ingredient2026/06/22CDE
甲磺酸左氧氟沙星 · No verified English nameHubei Ke Yi Pharma Co., Ltd. romanizedY20190004725ASalt-normalized ingredient2025/12/23CDE
甲磺酸左氧氟沙星 · No verified English nameHubei Wu Shi Pharma Co., Ltd. romanizedY20190004724ASalt-normalized ingredient2025/08/14CDE
盐酸左氧氟沙星 · No verified English nameSuzhou Hong Sen Pharma Co., Ltd. romanizedY20190004721ASalt-normalized ingredient2025/08/14CDE
盐酸左氧氟沙星 · No verified English nameJiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY20190004686ASalt-normalized ingredient—CDE
乳酸左氧氟沙星 · No verified English nameHunan Zhong Qi Pharmaceutical Co., Ltd. Yue Yang Branch romanizedY20190004649ASalt-normalized ingredient—CDE
甲磺酸左氧氟沙星 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20190004613ASalt-normalized ingredient2025/09/06CDE
甲磺酸左氧氟沙星 · No verified English nameKai Feng Pharmaceutical (Group) Co., Ltd. romanizedY20190004437ASalt-normalized ingredient2024/11/01CDE
甲磺酸左氧氟沙星 · No verified English nameZhejiang Zhe Bei Pharma Co., Ltd. romanizedY20190004320ASalt-normalized ingredient2024/12/11CDE
甲磺酸左氧氟沙星 · No verified English nameHainan Zhong He Pharma Co., Ltd. romanizedY20190004245ASalt-normalized ingredient2024/07/11CDE
盐酸左氧氟沙星 · No verified English nameLiaoning Yao Lian Pharmaceutical Co., Ltd. romanizedY20190004150ASalt-normalized ingredient2025/06/19CDE
甲磺酸左氧氟沙星 · No verified English nameJin Cheng Hai Si Pharmaceutical Co., Ltd. romanizedY20190003992ASalt-normalized ingredient2025/05/29CDE
乳酸左氧氟沙星 · No verified English nameJiangxi Da Di Pharmaceutical Co., Ltd. romanizedY20190003958ASalt-normalized ingredient2025/08/12CDE
盐酸左氧氟沙星 · No verified English nameJiangxi Da Di Pharmaceutical Co., Ltd. romanizedY20190003957ASalt-normalized ingredient2025/08/12CDE
甲磺酸左氧氟沙星 · No verified English nameHua Run Shuang He Pharma Co., Ltd. romanizedY20190003928ASalt-normalized ingredient—CDE
甲磺酸左氧氟沙星 · No verified English nameZhuhai Run Dou Pharmaceutical Co., Ltd. romanizedY20190002952ASalt-normalized ingredient2026/06/23CDE
盐酸左氧氟沙星 · No verified English nameHenan Lan Tu Pharmaceutical Co., Ltd. romanizedY20190002907ASalt-normalized ingredient—CDE
盐酸左氧氟沙星 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20190002697ASalt-normalized ingredient2025/04/16CDE
乳酸左氧氟沙星 · No verified English nameZhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY20190002523ASalt-normalized ingredient2026/01/13CDE
盐酸左氧氟沙星 · No verified English nameZhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY20190002497ASalt-normalized ingredient2025/03/18CDE
盐酸左氧氟沙星 · No verified English nameZhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.Y20190002276ASalt-normalized ingredient2024/11/09CDE
甲磺酸左氧氟沙星 · No verified English nameZhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.Y20190002247ASalt-normalized ingredient2024/12/07CDE
甲磺酸左氧氟沙星 · No verified English nameLiao Yuan Shi Bai Kang Pharma Co., Ltd. romanizedY20190002140ASalt-normalized ingredient2025/03/26CDE
盐酸左氧氟沙星 · No verified English nameHainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedY20190001907ASalt-normalized ingredient2024/07/11CDE
乳酸左氧氟沙星 · No verified English nameZhejiang Xian Feng Technology Group Co., Ltd. romanizedY20190001767ASalt-normalized ingredient—CDE
甲磺酸左氧氟沙星 · No verified English nameShanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanizedY20190001742ASalt-normalized ingredient2025/01/25CDE
甲磺酸左氧氟沙星 · No verified English nameShanxi Pu De Pharma Co., Ltd. romanizedY20190001734ASalt-normalized ingredient2025/02/14CDE
盐酸左氧氟沙星 · No verified English nameZhuhai Lian Bang Pharmaceutical Co., Ltd. romanizedY20190001635ASalt-normalized ingredient2024/12/25CDE
乳酸左氧氟沙星 · No verified English nameShanghai Zhong Xi San Wei Pharma Co., Ltd. romanizedY20190001481ASalt-normalized ingredient2025/01/27CDE
盐酸左氧氟沙星 · No verified English nameZhejiang Lang Hua Pharmaceutical Co., Ltd. romanizedY20190001466ASalt-normalized ingredient2024/08/23CDE
甲磺酸左氧氟沙星 · No verified English nameZhejiang Lang Hua Pharmaceutical Co., Ltd. romanizedY20190001396ASalt-normalized ingredient2024/10/22CDE
乳酸左氧氟沙星 · No verified English nameZhejiang Lang Hua Pharmaceutical Co., Ltd. romanizedY20190001395ASalt-normalized ingredient2024/09/15CDE
左氧氟沙星 · No verified English nameZhejiang Chang Hai Pharmaceutical Co., Ltd. romanizedY20190000367AExact ingredient2023/07/28CDE
左氧氟沙星(供注射用) · No verified English nameZhejiang Lang Hua Pharmaceutical Co., Ltd. romanizedY20190000118AExact ingredient2026/05/20CDE
左氧氟沙星 · No verified English nameZhejiang Lang Hua Pharmaceutical Co., Ltd. romanizedY20180001384AExact ingredient2026/06/27CDE
左氧氟沙星 · No verified English nameZhejiang Si Tai Li Pharmaceutical Co., Ltd. romanizedY20180001433AExact ingredient2026/07/17CDE
左氧氟沙星 · No verified English nameZhejiang Dong Ya Pharma Co., Ltd. romanizedY20170002036AExact ingredient2026/11/05CDE
乳酸左氧氟沙星 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20170001975ASalt-normalized ingredient2022/10/12CDE
左氧氟沙星 · No verified English nameYi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedY20170000195AExact ingredient2023/10/31CDE

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. 2026/10/20Marketing application approved

    Ying Ke Rui (Zhuhai Jin Wan) Pharmaceutical Co., Ltd. romanized

    CYHS2500609 · 国药准字H20266303

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.

    View source · Table row 28 ↗
  2. 2026/10/14Accepted

    Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized

    CYHS2602543

    Fact date: 2026/10/14 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/09/23Accepted

    Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized

    CYHS2602399

    Fact date: 2026/09/23 · Site observation date: 2026/10/22

    View source ↗

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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