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Matched- Active ingredients (original)
- FINERENONE
- 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 approval2021/07/09
ANDA applications0
RLD applicantBAYER HEALTHCARE PHARMACEUTICALS INC
Currently marketed products: 3 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| N215341-001 | KERENDIA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | FINERENONE: 10MG | 2021/07/09 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N215341-002 | KERENDIA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | FINERENONE: 20MG | 2021/07/09 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N215341-003 | KERENDIA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | FINERENONE: 40MG | 2025/07/11 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration2035/07/29
Substance patent expiration (DS flag)2035/07/29
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 |
|---|---|---|---|---|---|---|
| N215341-001 | 8436180 | 2033/08/26 | Y / Y | — | — | openFDA ↗ |
| N215341-001 | RE49826 | 2035/07/29 | Y / — | — | — | openFDA ↗ |
| N215341-002 | 8436180 | 2033/08/26 | Y / Y | — | — | openFDA ↗ |
| N215341-002 | RE49826 | 2035/07/29 | Y / — | — | — | openFDA ↗ |
| N215341-003 | 8436180 | 2033/08/26 | Y / Y | — | — | openFDA ↗ |
| N215341-003 | RE49826 | 2035/07/29 | Y / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2029/09/16
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N215341-001 | I-970 | 2028/07/11 | openFDA ↗ |
| N215341-001 | I-998 | 2029/09/16 | openFDA ↗ |
| N215341-001 | NCE | 2026/07/09 | openFDA ↗ |
| N215341-002 | I-970 | 2028/07/11 | openFDA ↗ |
| N215341-002 | I-998 | 2029/09/16 | openFDA ↗ |
| N215341-002 | NCE | 2026/07/09 | openFDA ↗ |
| N215341-003 | I-998 | 2029/09/16 | openFDA ↗ |
| N215341-003 | NCE | 2026/07/09 | openFDA ↗ |
| N215341-003 | NS | 2028/07/11 | openFDA ↗ |
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 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | 2026/04/29 | Official source ↗ |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 国药准字H2026381310mg | 2026/03/31 | Official source ↗ |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 国药准字H2026381420mg | 2026/03/31 | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | 2026/03/25 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2025607410mg | 2025/11/25 | Official source ↗ |
| Bayer AG | 国药准字HJ2022005710mg | 2022/06/28 | Official source ↗ |
| Bayer AG | 国药准字HJ2022005820mg | 2022/06/28 | Official source ↗ |
NHSA approval numbers 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2025607410mg | — | Official source ↗ |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 国药准字H2026381310mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Bayer AG | 国药准字HJ2022005710mg | — | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2025607410mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Bayer AG | 国药准字HJ2022005710mg | — | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2025607410mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Bayer AG | 国药准字HJ2022005710mg | — | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2025607410mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026369610mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2026420220mg | — | Official source ↗ |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 国药准字H2026381420mg | — | Official source ↗ |
| Bayer AG | 国药准字HJ2022005820mg | — | Official source ↗ |
| Bayer AG | 国药准字HJ2022005820mg | — | Official source ↗ |
| Bayer AG | 国药准字HJ2022005820mg | — | Official source ↗ |
Under review 69
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2601070 | 2026/05/12 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2502708 | 2025/07/28 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2502707 | 2025/07/28 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2503393 | 2025/09/13 | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CYHS2503826 | 2025/10/29 | Official source ↗ |
| Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CYHS2503825 | 2025/10/29 | Official source ↗ |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CYHS2501400 | 2025/04/11 | Official source ↗ |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CYHS2501399 | 2025/04/11 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2600107 | 2026/01/09 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2600106 | 2026/01/09 | Official source ↗ |
| Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | CYHS2502822 | 2025/08/05 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | CYHS2504451 | 2025/12/26 | Official source ↗ |
| Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | CYHS2504310 | 2025/12/18 | Official source ↗ |
| Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | CYHS2504309 | 2025/12/18 | Official source ↗ |
| Henan Zhong Jie Pharma Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CYHB2601557 | 2026/08/17 | Official source ↗ |
| Bayer AG; Bayer Healthcare Company Ltd. | JXHS2600089 | 2026/08/13 | Official source ↗ |
| Bayer AG; Bayer Healthcare Company Ltd. | JXHS2600088 | 2026/08/13 | Official source ↗ |
| Bayer AG; Bayer Healthcare Company Ltd. | JYHZ2600161 | 2026/07/06 | Official source ↗ |
| Bayer AG; Bayer Healthcare Company Ltd. | JYHZ2600160 | 2026/07/06 | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2600843 | 2026/04/11 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHB2600609 | 2026/03/27 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHB2600608 | 2026/03/27 | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | CYHS2600656 | 2026/03/13 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2600608 | 2026/03/04 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2600607 | 2026/03/04 | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | CYHS2600567 | 2026/02/27 | Official source ↗ |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600466 | 2026/02/13 | Official source ↗ |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600464 | 2026/02/13 | Official source ↗ |
| Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600289 | 2026/01/28 | Official source ↗ |
| Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600288 | 2026/01/28 | Official source ↗ |
| Gan Li Pharma Shandong Co., Ltd. romanized | CYHS2600222 | 2026/01/20 | Official source ↗ |
| Zhejiang Wei Kang Pharmaceutical Co., Ltd. romanized | CYHS2600091 | 2026/01/08 | Official source ↗ |
| Shandong Ze Yu Bio Co., Ltd. romanized | CYHS2600018 | 2026/01/05 | Official source ↗ |
| Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2504482 | 2025/12/30 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | CYHS2504299 | 2025/12/17 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2504224 | 2025/12/09 | Official source ↗ |
| Tian Da Pharma (Zhuhai) Co., Ltd. romanized | CYHS2504216 | 2025/12/09 | Official source ↗ |
| Tian Da Pharma (Zhuhai) Co., Ltd. romanized | CYHS2504214 | 2025/12/09 | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHS2504169 | 2025/12/04 | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHS2504168 | 2025/12/04 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | CYHS2503911 | 2025/11/08 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2503909 | 2025/11/08 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2503908 | 2025/11/08 | Official source ↗ |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | CYHS2503802 | 2025/10/28 | Official source ↗ |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | CYHS2503801 | 2025/10/28 | Official source ↗ |
| Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | CYHS2503781 | 2025/10/24 | Official source ↗ |
| Su Zhou Yi Fan Pharma Co., Ltd. romanized | CYHS2503668 | 2025/10/14 | Official source ↗ |
| Su Zhou Yi Fan Pharma Co., Ltd. romanized | CYHS2503667 | 2025/10/14 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | CYHS2503333 | 2025/09/09 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | CYHS2503332 | 2025/09/09 | Official source ↗ |
| Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHS2503245 | 2025/09/03 | Official source ↗ |
| Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHS2503244 | 2025/09/03 | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2503019 | 2025/08/19 | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | CYHS2502931 | 2025/08/12 | Official source ↗ |
| Zhejiang Bei De Pharma Co., Ltd. romanized | CYHS2502889 | 2025/08/09 | Official source ↗ |
| Zhejiang Bei De Pharma Co., Ltd. romanized | CYHS2502888 | 2025/08/09 | Official source ↗ |
| Jiangxi Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CYHS2502783 | 2025/08/02 | Official source ↗ |
| Jiangxi Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CYHS2502781 | 2025/08/02 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | CYHS2502654 | 2025/07/23 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | CYHS2502653 | 2025/07/23 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2502407 | 2025/07/08 | Official source ↗ |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | CYHS2501561 | 2025/04/25 | Official source ↗ |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | CYHS2501559 | 2025/04/25 | Official source ↗ |
| Tianjin Han Rui Pharma Co., Ltd. romanized | CYHS2501396 | 2025/04/11 | Official source ↗ |
| Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized | CYHS2501256 | 2025/04/03 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2500751 | 2025/02/17 | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2500538 | 2025/01/27 | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2500537 | 2025/01/27 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | CYHS2404406 | 2024/12/19 | Official source ↗ |
Generic-filing companies this year 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2601070 | 2026/05/12 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2600107 | 2026/01/09 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2600106 | 2026/01/09 | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2600843 | 2026/04/11 | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | CYHS2600656 | 2026/03/13 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2600608 | 2026/03/04 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2600607 | 2026/03/04 | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | CYHS2600567 | 2026/02/27 | Official source ↗ |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600466 | 2026/02/13 | Official source ↗ |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600464 | 2026/02/13 | Official source ↗ |
| Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600289 | 2026/01/28 | Official source ↗ |
| Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600288 | 2026/01/28 | Official source ↗ |
| Gan Li Pharma Shandong Co., Ltd. romanized | CYHS2600222 | 2026/01/20 | Official source ↗ |
| Zhejiang Wei Kang Pharmaceutical Co., Ltd. romanized | CYHS2600091 | 2026/01/08 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2600086 | 2026/01/08 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2600085 | 2026/01/08 | Official source ↗ |
| Shandong Ze Yu Bio Co., Ltd. romanized | CYHS2600018 | 2026/01/05 | Official source ↗ |
API companies with A status 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20250000371 | 2026/09/16 | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | Y20250000120 | 2026/07/21 | Official source ↗ |
| Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20250000132 | 2026/09/13 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20240001451 | 2026/07/21 | Official source ↗ |
| Hubei Tian Shu Pharma Co., Ltd. romanized | Y20240001505 | 2026/09/21 | Official source ↗ |
| Chongqing Lai Mei Long Yu Pharma Co., Ltd. romanized | Y20240001478 | 2026/09/10 | Official source ↗ |
| Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20240001497 | 2026/06/17 | Official source ↗ |
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20240001327 | 2026/07/14 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20240001229 | 2026/09/17 | Official source ↗ |
| Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20240001148 | 2026/03/13 | Official source ↗ |
| Chongqing Kai Lin Pharmaceutical Co., Ltd. romanized | Y20240000712 | 2026/06/01 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20240000913 | 2026/03/26 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20240000768 | 2026/02/09 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240000862 | 2026/07/15 | Official source ↗ |
| Suzhou Zheng Ji Pharma Co., Ltd. romanized | Y20240000782 | 2026/04/14 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20230001187 | 2025/09/16 | 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
- CDE chemical-drug catalogue detail ↗ · idCode=3918d8c860d08b21ec0a27222445df0a
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