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Sign in to subscribeAs 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
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.
| Brand name | Applicant (source text) | Application number | Dosage 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 |
| Brand name | Applicant (source text) | Application number | Dosage 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.
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: 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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Santen Pharmaceutical Co.,Ltd. | Santen Pharmaceutical Co., Ltd. Ying Gai Wei Santen Pharmaceutical Co., Ltd. Noto Plant romanized | H20150278 | 2004/11/15 | 5ml:24.4mg | 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: 55 distinct approval numbers and 47 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H20264249 | See source | Category A | XS01AEZ074G010010100315 | NHSA |
| Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized | 国药准字H20234675 | See source | Category A | XS01AEZ074G010010100547 | NHSA |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20233723 | See source | Category A | XS01AEZ074G010010100548 | NHSA |
| Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20183227 | See source | Category A | XS01AEZ074G010010100612 | NHSA |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20203593 | See source | Category A | XS01AEZ074G010010101322 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148 | See source | Category A | XS01AEZ074G010010101442 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20253857 | See source | Category A | XS01AEZ074G010010101503 | NHSA |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H20243939 | See source | Category A | XS01AEZ074G010010101518 | NHSA |
| Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized | 国药准字H20173405 | See source | Category A | XS01AEZ074G010010101652 | NHSA |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20203092 | See source | Category A | XS01AEZ074G010010101749 | NHSA |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H20183382 | See source | Category A | XS01AEZ074G010010101955 | NHSA |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249743 | See source | Category A | XS01AEZ074G010010101967 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20203457 | See source | Category A | XS01AEZ074G010010102087 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20093808 | See source | Category A | XS01AEZ074G010010102138 | NHSA |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118 | See source | Category A | XS01AEZ074G010010102680 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20233998 | See source | Category A | XS01AEZ074G010010102733 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20256148 | See source | Category A | XS01AEZ074G010010102763 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930 | See source | Category A | XS01AEZ074G010010103358 | NHSA |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20254737 | See source | Category A | XS01AEZ074G010010103454 | NHSA |
| Anhui Huan Qiu Pharma Co., Ltd. romanized | 国药准字H20243616 | See source | Category A | XS01AEZ074G010010104303 | NHSA |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H20254640 | See source | Category A | XS01AEZ074G010010104423 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010104693 | NHSA |
| Fujian Tian Quan Pharma Co., Ltd. romanized | 国药准字H20265172 | See source | Category A | XS01AEZ074G010010104817 | NHSA |
| Yunnan Dai Yao Co., Ltd. romanized | 国药准字H20244929 | See source | Category A | XS01AEZ074G010010105619 | NHSA |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263023 | See source | Category A | XS01AEZ074G010010105816 | NHSA |
| Santen Pharmaceutical Co.,Ltd. | 国药准字J20150106 | 5ml:24.4mg | Category A | XS01AEZ074G010010109591 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122 | See source | Category A | XS01AEZ074G010010109920 | NHSA |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H20254733 | See source | Category A | XS01AEZ074G010010110144 | NHSA |
| Shandong Guang Ming Pharma Co., Ltd. romanized | 国药准字H20243581 | See source | Category A | XS01AEZ074G010010180494 | NHSA |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20203500 | See source | Category A | XS01AEZ074G010010181567 | NHSA |
| Shenzhen Shi Rui Lin Pharmaceuticals Co., Ltd. romanized | 国药准字H20213721 | See source | Category A | XS01AEZ074G010010183060 | NHSA |
| Shijiazhuang Kai Sai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249227 | See source | Category A | XS01AEZ074G010010183164 | NHSA |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H20254169 | See source | Category A | XS01AEZ074G010010183191 | NHSA |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H20223131 | See source | Category A | XS01AEZ074G010010183223 | NHSA |
| Ai Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20234223 | See source | Category A | XS01AEZ074G010010183549 | NHSA |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20244928 | See source | Category A | XS01AEZ074G010010183562 | NHSA |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567 | See source | Category A | XS01AEZ074G010010184738 | NHSA |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | 国药准字H20263115 | See source | Category A | XS01AEZ074G010010184784 | NHSA |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582 | See source | Category A | XS01AEZ074G010010185039 | NHSA |
| Anhui Kang Rong Pharma Co., Ltd. romanized | 国药准字H20264702 | See source | Category A | XS01AEZ074G010010185072 | NHSA |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20233723 | See source | Category A | XS01AEZ074G010010200548 | NHSA |
| Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20183227 | See source | Category A | XS01AEZ074G010010200612 | NHSA |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20203593 | See source | Category A | XS01AEZ074G010010201322 | NHSA |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H20243939 | See source | Category A | XS01AEZ074G010010201518 | NHSA |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249743 | See source | Category A | XS01AEZ074G010010201967 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20233998 | See source | Category A | XS01AEZ074G010010202733 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930 | See source | Category A | XS01AEZ074G010010203358 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010204693 | NHSA |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263023 | See source | Category A | XS01AEZ074G010010205816 | NHSA |
| Santen Pharmaceutical Co.,Ltd. | 国药准字HJ20150278 | See source | Category A | XS01AEZ074G010010278986 | NHSA |
| Shandong Guang Ming Pharma Co., Ltd. romanized | 国药准字H20243581 | See source | Category A | XS01AEZ074G010010280494 | NHSA |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H20254169 | See source | Category A | XS01AEZ074G010010283191 | NHSA |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567 | See source | Category A | XS01AEZ074G010010284738 | NHSA |
| Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20183227 | See source | Category A | XS01AEZ074G010010300612 | NHSA |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249743 | See source | Category A | XS01AEZ074G010010301967 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930 | See source | Category A | XS01AEZ074G010010303358 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010304693 | NHSA |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263023 | See source | Category A | XS01AEZ074G010010305816 | NHSA |
| Santen Pharmaceutical Co.,Ltd. | 国药准字HJ20150278 | See source | Category A | XS01AEZ074G010010378986 | NHSA |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567 | See source | Category A | XS01AEZ074G010010384738 | NHSA |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930 | See source | Category A | XS01AEZ074G010010403358 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010404693 | NHSA |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567 | See source | Category A | XS01AEZ074G010010484738 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010504693 | NHSA |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567 | See source | Category A | XS01AEZ074G010010584738 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010604693 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010704693 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661 | See source | Category A | XS01AEZ074G010010804693 | NHSA |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20217093 | See source | Category A | XS01AEZ074G010020101322 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148 | See source | Category A | XS01AEZ074G010020101442 | NHSA |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H20243939 | See source | Category A | XS01AEZ074G010020101518 | NHSA |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H20223058 | See source | Category A | XS01AEZ074G010020101955 | NHSA |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118 | See source | Category A | XS01AEZ074G010020102680 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322 | See source | Category A | XS01AEZ074G010020102733 | NHSA |
| Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20205052 | See source | Category A | XS01AEZ074G010020109591 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122 | See source | Category A | XS01AEZ074G010020109920 | NHSA |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124 | See source | Category A | XS01AEZ074G010020181567 | NHSA |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033 | See source | Category A | XS01AEZ074G010020183060 | NHSA |
| Ai Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20234222 | See source | Category A | XS01AEZ074G010020183549 | NHSA |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20249151 | See source | Category A | XS01AEZ074G010020183562 | NHSA |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582 | See source | Category A | XS01AEZ074G010020185039 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322 | See source | Category A | XS01AEZ074G010020202733 | NHSA |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124 | See source | Category A | XS01AEZ074G010020281567 | NHSA |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033 | See source | Category A | XS01AEZ074G010020283060 | NHSA |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582 | See source | Category A | XS01AEZ074G010020285039 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322 | See source | Category A | XS01AEZ074G010020302733 | NHSA |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124 | See source | Category A | XS01AEZ074G010020381567 | NHSA |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033 | See source | Category A | XS01AEZ074G010020383060 | NHSA |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582 | See source | Category A | XS01AEZ074G010020385039 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322 | See source | Category A | XS01AEZ074G010020402733 | NHSA |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124 | See source | Category A | XS01AEZ074G010020481567 | NHSA |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033 | See source | Category A | XS01AEZ074G010020483060 | NHSA |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582 | See source | Category A | XS01AEZ074G010020485039 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322 | See source | Category A | XS01AEZ074G010020502733 | NHSA |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124 | See source | Category A | XS01AEZ074G010020581567 | NHSA |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033 | See source | Category A | XS01AEZ074G010020583060 | NHSA |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322 | See source | Category A | XS01AEZ074G010020602733 | NHSA |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033 | See source | Category A | XS01AEZ074G010020683060 | NHSA |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H20256135 | See source | Category A | XS01AEZ074G010030100600 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148 | See source | Category A | XS01AEZ074G010030101442 | NHSA |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516 | See source | Category A | XS01AEZ074G010030102298 | NHSA |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118 | See source | Category A | XS01AEZ074G010030102680 | NHSA |
| Ningxia Kang Ya Pharma Co., Ltd. romanized | 国药准字H20223509 | See source | Category A | XS01AEZ074G010030105911 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122 | See source | Category A | XS01AEZ074G010030109920 | NHSA |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582 | See source | Category A | XS01AEZ074G010030185039 | NHSA |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516 | See source | Category A | XS01AEZ074G010030202298 | NHSA |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516 | See source | Category A | XS01AEZ074G010030302298 | NHSA |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516 | See source | Category A | XS01AEZ074G010030402298 | NHSA |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516 | See source | Category A | XS01AEZ074G010030502298 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148 | See source | Category A | XS01AEZ074G010040101442 | NHSA |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118 | See source | Category A | XS01AEZ074G010040102680 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102 | See source | Category A | XS01AEZ074G010040109920 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102 | See source | Category A | XS01AEZ074G010040209920 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102 | See source | Category A | XS01AEZ074G010040309920 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102 | See source | Category A | XS01AEZ074G010040409920 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148 | See source | Category A | XS01AEZ074G010050101442 | NHSA |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118 | See source | Category A | XS01AEZ074G010050102680 | NHSA |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122 | See source | Category A | XS01AEZ074G010050109920 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148 | See source | Category A | XS01AEZ074G010060101442 | NHSA |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118 | See source | Category A | XS01AEZ074G010070102680 | NHSA |
| Hebei He Du Pharma Co., Ltd. romanized | 国药准字H20255153 | See source | Category A | XS01AEZ074G010080102680 | NHSA |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20255627 | See source | Category A | XS01AEZ074G010090102680 | 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: 16 filings and 13 distinct first applicants.
Generic 13 · Supplement 3
Loaded records: 11 filings and 8 distinct first applicants.
Non-component matches: 51 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 左氧氟沙星 · No verified English name | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20220001323 | A | Exact ingredient | 2025/09/28 | CDE |
| 左氧氟沙星 · No verified English name | QUIMICA SINTETICA S.A. | Y20220000523 | A | Exact ingredient | 2024/11/29 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20190009874 | A | Exact ingredient | 2023/06/22 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20190009849 | A | Salt-normalized ingredient | 2025/04/02 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009764 | A | Salt-normalized ingredient | 2026/01/13 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20190009576 | A | Exact ingredient | 2024/12/10 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190009507 | A | Exact ingredient | 2024/11/09 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190009366 | A | Exact ingredient | 2024/10/12 | CDE |
| 左氧氟沙星 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009344 | A | Exact ingredient | 2025/01/08 | CDE |
| 左氧氟沙星 · No verified English name | DAIICHI SANKYO CO.,LTD. | Y20190009123 | A | Exact ingredient | 2024/11/12 | CDE |
| 左氧氟沙星 · No verified English name | DAIICHI SANKYO CO., LTD. | Y20190009121 | A | Exact ingredient | 2024/11/12 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190008943 | A | Salt-normalized ingredient | 2024/12/27 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | Y20190008856 | A | Salt-normalized ingredient | — | CDE |
| 盐酸左氧氟沙星 · No verified English name | Henan Kang Da Pharmaceutical Co., Ltd. romanized | Y20190007638 | A | Salt-normalized ingredient | 2024/07/20 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Y20190007461 | A | Exact ingredient | 2024/02/05 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20190007451 | A | Exact ingredient | 2024/02/08 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20190007450 | A | Salt-normalized ingredient | 2024/02/08 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20190007440 | A | Salt-normalized ingredient | 2024/01/17 | CDE |
| 左氧氟沙星 · No verified English name | Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | Y20190007089 | A | Exact ingredient | 2024/03/05 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Shanxi Pu De Pharma Co., Ltd. romanized | Y20190007045 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Hubei Si Huan Pharmaceutical Co., Ltd. romanized | Y20190006942 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
| 左氧氟沙星 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20190006790 | A | Exact ingredient | 2023/03/24 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20190006750 | A | Salt-normalized ingredient | 2025/08/22 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | Y20190006744 | A | Salt-normalized ingredient | — | CDE |
| 盐酸左氧氟沙星 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20190006709 | A | Salt-normalized ingredient | 2025/08/22 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Lu An Hua Yuan Pharmaceutical Co., Ltd. romanized | Y20190006541 | A | Salt-normalized ingredient | — | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Jiang Ling Ben Da Pharmaceutical Co., Ltd. romanized | Y20190006510 | A | Salt-normalized ingredient | — | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20190006264 | A | Salt-normalized ingredient | 2025/07/18 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Zhejiang Hang Kang Pharma Co., Ltd. romanized | Y20190006174 | A | Salt-normalized ingredient | — | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hainan Huluwa Pharmaceutical Group Co., Ltd. | Y20190006074 | A | Salt-normalized ingredient | 2024/07/11 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | Y20190006073 | A | Salt-normalized ingredient | 2024/07/12 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | Y20190005980 | A | Salt-normalized ingredient | 2025/06/11 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Sichuan Bai Li Pharma Co., Ltd. romanized | Y20190005950 | A | Salt-normalized ingredient | 2026/01/09 | CDE |
| 左氧氟沙星 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190005279 | A | Exact ingredient | 2025/09/18 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | Y20190004985 | A | Salt-normalized ingredient | 2026/06/22 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hubei Ke Yi Pharma Co., Ltd. romanized | Y20190004725 | A | Salt-normalized ingredient | 2025/12/23 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hubei Wu Shi Pharma Co., Ltd. romanized | Y20190004724 | A | Salt-normalized ingredient | 2025/08/14 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Suzhou Hong Sen Pharma Co., Ltd. romanized | Y20190004721 | A | Salt-normalized ingredient | 2025/08/14 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004686 | A | Salt-normalized ingredient | — | CDE |
| 乳酸左氧氟沙星 · No verified English name | Hunan Zhong Qi Pharmaceutical Co., Ltd. Yue Yang Branch romanized | Y20190004649 | A | Salt-normalized ingredient | — | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20190004613 | A | Salt-normalized ingredient | 2025/09/06 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190004437 | A | Salt-normalized ingredient | 2024/11/01 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Zhejiang Zhe Bei Pharma Co., Ltd. romanized | Y20190004320 | A | Salt-normalized ingredient | 2024/12/11 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hainan Zhong He Pharma Co., Ltd. romanized | Y20190004245 | A | Salt-normalized ingredient | 2024/07/11 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | Y20190004150 | A | Salt-normalized ingredient | 2025/06/19 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | Y20190003992 | A | Salt-normalized ingredient | 2025/05/29 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Jiangxi Da Di Pharmaceutical Co., Ltd. romanized | Y20190003958 | A | Salt-normalized ingredient | 2025/08/12 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Jiangxi Da Di Pharmaceutical Co., Ltd. romanized | Y20190003957 | A | Salt-normalized ingredient | 2025/08/12 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190003928 | A | Salt-normalized ingredient | — | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20190002952 | A | Salt-normalized ingredient | 2026/06/23 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Henan Lan Tu Pharmaceutical Co., Ltd. romanized | Y20190002907 | A | Salt-normalized ingredient | — | CDE |
| 盐酸左氧氟沙星 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002697 | A | Salt-normalized ingredient | 2025/04/16 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20190002523 | A | Salt-normalized ingredient | 2026/01/13 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20190002497 | A | Salt-normalized ingredient | 2025/03/18 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190002276 | A | Salt-normalized ingredient | 2024/11/09 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190002247 | A | Salt-normalized ingredient | 2024/12/07 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanized | Y20190002140 | A | Salt-normalized ingredient | 2025/03/26 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | Y20190001907 | A | Salt-normalized ingredient | 2024/07/11 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Zhejiang Xian Feng Technology Group Co., Ltd. romanized | Y20190001767 | A | Salt-normalized ingredient | — | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20190001742 | A | Salt-normalized ingredient | 2025/01/25 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Shanxi Pu De Pharma Co., Ltd. romanized | Y20190001734 | A | Salt-normalized ingredient | 2025/02/14 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | Y20190001635 | A | Salt-normalized ingredient | 2024/12/25 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized | Y20190001481 | A | Salt-normalized ingredient | 2025/01/27 | CDE |
| 盐酸左氧氟沙星 · No verified English name | Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190001466 | A | Salt-normalized ingredient | 2024/08/23 | CDE |
| 甲磺酸左氧氟沙星 · No verified English name | Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190001396 | A | Salt-normalized ingredient | 2024/10/22 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190001395 | A | Salt-normalized ingredient | 2024/09/15 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Chang Hai Pharmaceutical Co., Ltd. romanized | Y20190000367 | A | Exact ingredient | 2023/07/28 | CDE |
| 左氧氟沙星(供注射用) · No verified English name | Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190000118 | A | Exact ingredient | 2026/05/20 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20180001384 | A | Exact ingredient | 2026/06/27 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20180001433 | A | Exact ingredient | 2026/07/17 | CDE |
| 左氧氟沙星 · No verified English name | Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20170002036 | A | Exact ingredient | 2026/11/05 | CDE |
| 乳酸左氧氟沙星 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20170001975 | A | Salt-normalized ingredient | 2022/10/12 | CDE |
| 左氧氟沙星 · No verified English name | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20170000195 | A | Exact ingredient | 2023/10/31 | 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.
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 ↗CYHS2602543
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗CYHS2602399
Fact date: 2026/09/23 · Site observation date: 2026/10/22
View source ↗Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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