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Matched- Active ingredients (original)
- LORATADINE
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
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 approval2002/11/27
ANDA applications13
RLD applicantBAYER HEALTHCARE LLC
Currently marketed products: 13 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A075209-001 | LORATADINE | PLD ACQUISITIONS LLC | TABLET | ORAL | LORATADINE: 10MG | 2003/01/21 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A075790-001 | LORATADINE | PHARMAZONE | TABLET | ORAL | LORATADINE: 10MG | 2008/11/07 | N / N | DISCONTINUED | openFDA ↗ |
| A076134-001 | LORATADINE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | LORATADINE: 10MG | 2003/08/18 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076154-001 | LORATADINE | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | LORATADINE: 10MG | 2003/08/20 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076301-001 | LORATADINE | L PERRIGO CO | TABLET | ORAL | LORATADINE: 10MG | 2004/06/25 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076471-001 | LORATADINE | APOTEX INC | TABLET | ORAL | LORATADINE: 10MG | 2006/02/14 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A078447-001 | LORATADINE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | LORATADINE: 10MG | 2011/08/12 | N / N | DISCONTINUED | openFDA ↗ |
| A207569-001 | LORATADINE | ADAPTIS PHARMA PRIVATE LTD | TABLET | ORAL | LORATADINE: 10MG | 2019/03/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A208314-001 | LORATADINE | AUROBINDO PHARMA LTD | TABLET | ORAL | LORATADINE: 10MG | 2018/04/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A210722-001 | LORATADINE | GRANULES INDIA LTD | TABLET | ORAL | LORATADINE: 10MG | 2019/12/23 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A211718-001 | LORATADINE | HETERO LABS LTD UNIT V | TABLET | ORAL | LORATADINE: 10MG | 2023/07/28 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A214684-001 | LORATADINE | UNIQUE PHARMACEUTICAL LABORATORIES | TABLET | ORAL | LORATADINE: 10MG | 2021/01/07 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A219223-001 | LORATADINE | PHARMAZONE | TABLET | ORAL | LORATADINE: 10MG | 2024/11/21 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| N019658-002 | CLARITIN | BAYER HEALTHCARE LLC | TABLET | ORAL | LORATADINE: 10MG | 2002/11/27 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N019658-003 | CLARITIN HIVES RELIEF | BAYER HEALTHCARE LLC | TABLET | ORAL | LORATADINE: 10MG | 2003/11/19 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N021512-001 | LORATADINE | PERRIGO CO | TABLET | ORAL | LORATADINE: 10MG | 2004/06/24 | N / 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 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H2005003910mg | 2025/07/18 | Official source ↗ |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | 国药准字H2004039310mg | 2025/07/18 | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | 2025/03/03 | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | 2023/08/16 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H2004078410mg | 2022/09/29 | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | 2022/03/03 | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | 2022/03/03 | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | 2021/05/21 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | 2020/06/11 | Official source ↗ |
| Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized | 国药准字H2008013410mg | 2019/12/16 | Official source ↗ |
| Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized | 国药准字H1097041010mg | 1996/12/17 | Official source ↗ |
| Bayer SA-NV | H2016042410mg | 1993/01/03 | Official source ↗ |
NHSA approval numbers 34
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H2005003910mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized | 国药准字H2003129910mg | — | Official source ↗ |
| Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized | 国药准字H1097041010mg | — | Official source ↗ |
| Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized | 国药准字H2008013410mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H2004078410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Fei Sen You Si Ka Bi Hua Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2004055710mg | — | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Su Zhong Pharma Group Co., Ltd. romanized | 国药准字H2004101610mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H2003111210mg | — | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H2004165910mg | — | Official source ↗ |
| Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | 国药准字H2003000410mg | — | Official source ↗ |
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2003011210mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized | 国药准字H2005212010mg | — | Official source ↗ |
| Xian Yang Sen Pharmaceutical Co., Ltd. romanized | 国药准字H2007003010mg | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2008010510mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H2006706610mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Qingdao Shuang Jing Pharma Co., Ltd. romanized | 国药准字H2004049810mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Tian Shun Pharma Co., Ltd. romanized | 国药准字H2005168810mg | — | Official source ↗ |
| Zhejiang Hong Sheng Pharma Co., Ltd. romanized | 国药准字H2005215710mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | 国药准字H2004039310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H2005003910mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized | 国药准字H2003129910mg | — | Official source ↗ |
| Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized | 国药准字H1097041010mg | — | Official source ↗ |
| Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized | 国药准字H2008013410mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H2004078410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Su Zhong Pharma Group Co., Ltd. romanized | 国药准字H2004101610mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H2003111210mg | — | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H2004165910mg | — | Official source ↗ |
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2003011210mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized | 国药准字H2005212010mg | — | Official source ↗ |
| Xian Lan Tai Pharma Co., Ltd. romanized | 国药准字H2005192710mg | — | Official source ↗ |
| Xian Yang Sen Pharmaceutical Co., Ltd. romanized | 国药准字H2007003010mg | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2008010510mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H2006706610mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Tian Shun Pharma Co., Ltd. romanized | 国药准字H2005168810mg | — | Official source ↗ |
| Zhejiang Hong Sheng Pharma Co., Ltd. romanized | 国药准字H2005215710mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H2005003910mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized | 国药准字H2008013410mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H2004078410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Su Zhong Pharma Group Co., Ltd. romanized | 国药准字H2004101610mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized | 国药准字H2005212010mg | — | Official source ↗ |
| Xian Lan Tai Pharma Co., Ltd. romanized | 国药准字H2005192710mg | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2008010510mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Tian Shun Pharma Co., Ltd. romanized | 国药准字H2005168810mg | — | Official source ↗ |
| Zhejiang Hong Sheng Pharma Co., Ltd. romanized | 国药准字H2005215710mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | 国药准字H2004039310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H2004078410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Su Zhong Pharma Group Co., Ltd. romanized | 国药准字H2004101610mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized | 国药准字H2005212010mg | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2008010510mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H2006706610mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Zhejiang Hong Sheng Pharma Co., Ltd. romanized | 国药准字H2005215710mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | 国药准字H2004039310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2008010510mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Zhejiang Hong Sheng Pharma Co., Ltd. romanized | 国药准字H2005215710mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | 国药准字H2004039310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Huang He Pharma Co., Ltd. romanized | 国药准字H2005095310mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2005161810mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2003021310mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | 国药准字H2005221410mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized | 国药准字H2004188610mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 国药准字H2004577710mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H2004075510mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H2004079710mg | — | Official source ↗ |
| Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2004139610mg | — | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H2002017410mg | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2005000910mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H2005112510mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H2006040210mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H2005023310mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601192 | 2026/05/25 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHB2650121 | 2026/05/18 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2602061 | 2026/08/20 | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHB2601519 | 2026/08/10 | Official source ↗ |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | CYHB2650010 | 2026/01/09 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601192 | 2026/05/25 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2602061 | 2026/08/20 | Official source ↗ |
API companies with A status 34
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Morepen Laboratories Ltd | Y20230000137 | 2025/03/14 | Official source ↗ |
| Nanjing Yi Hua Pharma Co., Ltd. romanized | Y20230000259 | 2024/09/02 | Official source ↗ |
| Matrix Pharmacorp Private Limited | Y20190000502 | 2026/06/02 | Official source ↗ |
| Vasudha Pharma Chem Limited | Y20190009997 | 2026/07/30 | Official source ↗ |
| Schering-Plough Europe | Y20190009311 | — | Official source ↗ |
| Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190008725 | 2025/07/24 | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | Y20190008555 | 2024/11/01 | Official source ↗ |
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | Y20190008454 | 2024/12/07 | Official source ↗ |
| Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20190008305 | 2024/11/28 | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20190008269 | 2023/03/24 | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | Y20190008187 | 2026/05/18 | Official source ↗ |
| Chengdu Ao Bang Pharma Co., Ltd. romanized | Y20190008149 | 2025/12/26 | Official source ↗ |
| Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized | Y20190008142 | 2025/10/10 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20190008138 | 2025/09/16 | Official source ↗ |
| Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20190008134 | 2025/07/28 | Official source ↗ |
| Zhuhai Bao Shui Qu Li Zhu He Cheng Pharmaceutical Co., Ltd. romanized | Y20190008122 | 2024/11/21 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190008097 | 2024/06/12 | Official source ↗ |
| Hebei Yuan Sen Pharmaceutical Co., Ltd. romanized | Y20190008088 | 2025/05/07 | Official source ↗ |
| Shenzhen Hai Wang Pharma Co., Ltd. romanized | Y20190008061 | 2024/12/27 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190008022 | — | Official source ↗ |
| Guo Yao Group Zhi Jun (Suzhou) Pharmaceutical Co., Ltd. romanized | Y20190007939 | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20190007867 | 2026/02/03 | Official source ↗ |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | Y20190007865 | 2025/06/21 | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Y20190007851 | 2024/09/12 | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | Y20190007841 | 2024/09/28 | Official source ↗ |
| Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized | Y20190007837 | 2024/08/15 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190007818 | — | Official source ↗ |
| Henan Jiu Shi Pharmaceutical Co., Ltd. romanized | Y20190007802 | 2025/01/15 | Official source ↗ |
| Shandong Luo Xin Pharma Group Heng Xin Pharma Co., Ltd. romanized | Y20190007796 | 2025/02/20 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20190007772 | 2025/03/07 | Official source ↗ |
| Chongqing Xi Nan He Cheng Pharmaceutical Co., Ltd. romanized | Y20190007758 | — | Official source ↗ |
| Zhejiang Chang Ming Pharma Co., Ltd. romanized | Y20190007728 | — | Official source ↗ |
| Jinan Heng Ji Pharmaceutical Co., Ltd. romanized | Y20190002301 | 2025/05/13 | Official source ↗ |
| Jiangsu Jing Ye Pharmaceutical Co., Ltd. romanized | Y20170002304 | 2023/12/19 | 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 ↗ · 31-104 · 2020/11/20
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