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Sign in to subscribeLevofloxacin Eye Drops
Matched- Active ingredients (original)
- LEVOFLOXACIN
- Dosage form (original)
- SOLUTION/DROPS
- Route (original)
- OPHTHALMIC
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval2000/08/18
ANDA applications6
RLD applicantSANTEN INC
Currently marketed products: 2 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A076826-001 | LEVOFLOXACIN | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 0.5% | 2011/02/10 | N / N | DISCONTINUED | openFDA ↗ |
| A077700-001 | LEVOFLOXACIN | RISING PHARMA HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 0.5% | 2010/12/20 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078282-001 | LEVOFLOXACIN | RUBICON RESEARCH LTD | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 0.5% | 2010/12/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090268-001 | LEVOFLOXACIN | SCIEGEN PHARMACEUTICALS INC | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 0.5% | 2010/12/20 | N / N | DISCONTINUED | openFDA ↗ |
| A204899-001 | LEVOFLOXACIN | PHARMOBEDIENT CONSULTING LLC | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 0.5% | 2017/12/08 | N / N | DISCONTINUED | openFDA ↗ |
| A205600-001 | LEVOFLOXACIN | MICRO LABS LTD INDIA | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 1.5% | 2019/02/27 | N / N | DISCONTINUED | openFDA ↗ |
| N021199-001 | QUIXIN | SANTEN INC | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2000/08/18 | Y / N | DISCONTINUED | openFDA ↗ |
| N021571-001 | IQUIX | SANTEN INC | SOLUTION/DROPS | OPHTHALMIC | LEVOFLOXACIN: 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2004/03/01 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. 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.
Catalog holders 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Santen Pharmaceutical Co.,Ltd. | H201502785ml:24.4mg | 2004/11/15 | Official source ↗ |
NHSA approval numbers 55
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H20264249See source | — | Official source ↗ |
| Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized | 国药准字H20234675See source | — | Official source ↗ |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20233723See source | — | Official source ↗ |
| Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20183227See source | — | Official source ↗ |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20203593See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20253857See source | — | Official source ↗ |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H20243939See source | — | Official source ↗ |
| Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized | 国药准字H20173405See source | — | Official source ↗ |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20203092See source | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H20183382See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249743See source | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20203457See source | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20093808See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20233998See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20256148See source | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930See source | — | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20254737See source | — | Official source ↗ |
| Anhui Huan Qiu Pharma Co., Ltd. romanized | 国药准字H20243616See source | — | Official source ↗ |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H20254640See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Fujian Tian Quan Pharma Co., Ltd. romanized | 国药准字H20265172See source | — | Official source ↗ |
| Yunnan Dai Yao Co., Ltd. romanized | 国药准字H20244929See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263023See source | — | Official source ↗ |
| Santen Pharmaceutical Co.,Ltd. | 国药准字J201501065ml:24.4mg | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122See source | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H20254733See source | — | Official source ↗ |
| Shandong Guang Ming Pharma Co., Ltd. romanized | 国药准字H20243581See source | — | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20203500See source | — | Official source ↗ |
| Shenzhen Shi Rui Lin Pharmaceuticals Co., Ltd. romanized | 国药准字H20213721See source | — | Official source ↗ |
| Shijiazhuang Kai Sai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249227See source | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H20254169See source | — | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H20223131See source | — | Official source ↗ |
| Ai Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20234223See source | — | Official source ↗ |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20244928See source | — | Official source ↗ |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567See source | — | Official source ↗ |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | 国药准字H20263115See source | — | Official source ↗ |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582See source | — | Official source ↗ |
| Anhui Kang Rong Pharma Co., Ltd. romanized | 国药准字H20264702See source | — | Official source ↗ |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20233723See source | — | Official source ↗ |
| Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20183227See source | — | Official source ↗ |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20203593See source | — | Official source ↗ |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H20243939See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249743See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20233998See source | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263023See source | — | Official source ↗ |
| Santen Pharmaceutical Co.,Ltd. | 国药准字HJ20150278See source | — | Official source ↗ |
| Shandong Guang Ming Pharma Co., Ltd. romanized | 国药准字H20243581See source | — | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H20254169See source | — | Official source ↗ |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567See source | — | Official source ↗ |
| Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20183227See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249743See source | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263023See source | — | Official source ↗ |
| Santen Pharmaceutical Co.,Ltd. | 国药准字HJ20150278See source | — | Official source ↗ |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567See source | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H20244930See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249567See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20234661See source | — | Official source ↗ |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20217093See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148See source | — | Official source ↗ |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H20243939See source | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H20223058See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322See source | — | Official source ↗ |
| Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20205052See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122See source | — | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124See source | — | Official source ↗ |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033See source | — | Official source ↗ |
| Ai Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20234222See source | — | Official source ↗ |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20249151See source | — | Official source ↗ |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322See source | — | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124See source | — | Official source ↗ |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033See source | — | Official source ↗ |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322See source | — | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124See source | — | Official source ↗ |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033See source | — | Official source ↗ |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322See source | — | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124See source | — | Official source ↗ |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033See source | — | Official source ↗ |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322See source | — | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20217124See source | — | Official source ↗ |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20247322See source | — | Official source ↗ |
| Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20223033See source | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H20256135See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118See source | — | Official source ↗ |
| Ningxia Kang Ya Pharma Co., Ltd. romanized | 国药准字H20223509See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122See source | — | Official source ↗ |
| Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263582See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20233516See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20247102See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118See source | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H20203122See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20103148See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20113118See source | — | Official source ↗ |
| Hebei He Du Pharma Co., Ltd. romanized | 国药准字H20255153See source | — | Official source ↗ |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20255627See source | — | Official source ↗ |
Under review 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized | CYHS2602543 | 2026/10/14 | Official source ↗ |
| Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | CYHS2602399 | 2026/09/23 | Official source ↗ |
| Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601996 | 2026/08/13 | Official source ↗ |
| Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601995 | 2026/08/13 | Official source ↗ |
| Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2601794 | 2026/07/27 | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHB2601378 | 2026/07/21 | Official source ↗ |
| Heilongjiang Xian Dong Pharma Co., Ltd. romanized | CYHS2601622 | 2026/07/07 | Official source ↗ |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHB2601277 | 2026/07/07 | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | CYHS2600681 | 2026/03/19 | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | CYHS2600680 | 2026/03/19 | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | CYHS2600679 | 2026/03/19 | Official source ↗ |
| Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized | CYHS2600542 | 2026/02/26 | Official source ↗ |
| Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanized | CYHS2504524 | 2026/01/04 | Official source ↗ |
| Wuhan Wu Jing Pharma Co., Ltd. romanized | CYHS2504307 | 2025/12/17 | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHB2501931 | 2025/09/28 | Official source ↗ |
| Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHS2502440 | 2025/07/09 | Official source ↗ |
Generic-filing companies this year 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized | CYHS2602543 | 2026/10/14 | Official source ↗ |
| Shandong Hai Shan Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | CYHS2602399 | 2026/09/23 | Official source ↗ |
| Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601996 | 2026/08/13 | Official source ↗ |
| Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Sichuan He Yi Pharmaceutical Co., Ltd. romanized | CYHS2601995 | 2026/08/13 | Official source ↗ |
| Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2601794 | 2026/07/27 | Official source ↗ |
| Heilongjiang Xian Dong Pharma Co., Ltd. romanized | CYHS2601622 | 2026/07/07 | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | CYHS2600681 | 2026/03/19 | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | CYHS2600680 | 2026/03/19 | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | CYHS2600679 | 2026/03/19 | Official source ↗ |
| Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized | CYHS2600542 | 2026/02/26 | Official source ↗ |
| Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanized | CYHS2504524 | 2026/01/04 | Official source ↗ |
API companies with A status 51
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20220001323 | 2025/09/28 | Official source ↗ |
| QUIMICA SINTETICA S.A. | Y20220000523 | 2024/11/29 | Official source ↗ |
| Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20190009874 | 2023/06/22 | Official source ↗ |
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20190009849 | 2025/04/02 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009764 | 2026/01/13 | Official source ↗ |
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20190009576 | 2024/12/10 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190009507 | 2024/11/09 | Official source ↗ |
| Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190009366 | 2024/10/12 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009344 | 2025/01/08 | Official source ↗ |
| DAIICHI SANKYO CO.,LTD. | Y20190009123 | 2024/11/12 | Official source ↗ |
| DAIICHI SANKYO CO., LTD. | Y20190009121 | 2024/11/12 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190008943 | 2024/12/27 | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | Y20190008856 | — | Official source ↗ |
| Henan Kang Da Pharmaceutical Co., Ltd. romanized | Y20190007638 | 2024/07/20 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Y20190007461 | 2024/02/05 | Official source ↗ |
| Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20190007451 | 2024/02/08 | Official source ↗ |
| Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20190007450 | 2024/02/08 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20190007440 | 2024/01/17 | Official source ↗ |
| Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | Y20190007089 | 2024/03/05 | Official source ↗ |
| Shanxi Pu De Pharma Co., Ltd. romanized | Y20190007045 | 2023/03/24 | Official source ↗ |
| Hubei Si Huan Pharmaceutical Co., Ltd. romanized | Y20190006942 | 2023/03/24 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20190006790 | 2023/03/24 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20190006750 | 2025/08/22 | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | Y20190006744 | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20190006709 | 2025/08/22 | Official source ↗ |
| Lu An Hua Yuan Pharmaceutical Co., Ltd. romanized | Y20190006541 | — | Official source ↗ |
| Jiang Ling Ben Da Pharmaceutical Co., Ltd. romanized | Y20190006510 | — | Official source ↗ |
| Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20190006264 | 2025/07/18 | Official source ↗ |
| Zhejiang Hang Kang Pharma Co., Ltd. romanized | Y20190006174 | — | Official source ↗ |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | Y20190006074 | 2024/07/11 | Official source ↗ |
| Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | Y20190006073 | 2024/07/12 | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | Y20190005980 | 2025/06/11 | Official source ↗ |
| Sichuan Bai Li Pharma Co., Ltd. romanized | Y20190005950 | 2026/01/09 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190005279 | 2025/09/18 | Official source ↗ |
| Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | Y20190004985 | 2026/06/22 | Official source ↗ |
| Hubei Ke Yi Pharma Co., Ltd. romanized | Y20190004725 | 2025/12/23 | Official source ↗ |
| Hubei Wu Shi Pharma Co., Ltd. romanized | Y20190004724 | 2025/08/14 | Official source ↗ |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | Y20190004721 | 2025/08/14 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004686 | — | Official source ↗ |
| Hunan Zhong Qi Pharmaceutical Co., Ltd. Yue Yang Branch romanized | Y20190004649 | — | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | Y20190004613 | 2025/09/06 | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190004437 | 2024/11/01 | Official source ↗ |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized | Y20190004320 | 2024/12/11 | Official source ↗ |
| Hainan Zhong He Pharma Co., Ltd. romanized | Y20190004245 | 2024/07/11 | Official source ↗ |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | Y20190004150 | 2025/06/19 | Official source ↗ |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | Y20190003992 | 2025/05/29 | Official source ↗ |
| Jiangxi Da Di Pharmaceutical Co., Ltd. romanized | Y20190003958 | 2025/08/12 | Official source ↗ |
| Jiangxi Da Di Pharmaceutical Co., Ltd. romanized | Y20190003957 | 2025/08/12 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190003928 | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20190002952 | 2026/06/23 | Official source ↗ |
| Henan Lan Tu Pharmaceutical Co., Ltd. romanized | Y20190002907 | — | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002697 | 2025/04/16 | Official source ↗ |
| Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20190002523 | 2026/01/13 | Official source ↗ |
| Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20190002497 | 2025/03/18 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190002276 | 2024/11/09 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190002247 | 2024/12/07 | Official source ↗ |
| Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanized | Y20190002140 | 2025/03/26 | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | Y20190001907 | 2024/07/11 | Official source ↗ |
| Zhejiang Xian Feng Technology Group Co., Ltd. romanized | Y20190001767 | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20190001742 | 2025/01/25 | Official source ↗ |
| Shanxi Pu De Pharma Co., Ltd. romanized | Y20190001734 | 2025/02/14 | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | Y20190001635 | 2024/12/25 | Official source ↗ |
| Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized | Y20190001481 | 2025/01/27 | Official source ↗ |
| Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190001466 | 2024/08/23 | Official source ↗ |
| Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190001396 | 2024/10/22 | Official source ↗ |
| Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190001395 | 2024/09/15 | Official source ↗ |
| Zhejiang Chang Hai Pharmaceutical Co., Ltd. romanized | Y20190000367 | 2023/07/28 | Official source ↗ |
| Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20190000118 | 2026/05/20 | Official source ↗ |
| Zhejiang Lang Hua Pharmaceutical Co., Ltd. romanized | Y20180001384 | 2026/06/27 | Official source ↗ |
| Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20180001433 | 2026/07/17 | Official source ↗ |
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20170002036 | 2026/11/05 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20170001975 | 2022/10/12 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20170000195 | 2023/10/31 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 54-32 · 2022/06/16
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