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Matched- Active ingredients (original)
- EZETIMIBE
- 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 approval2002/10/25
ANDA applications16
RLD applicantORGANON LLC A SUB OF ORGANON AND CO
Currently marketed products: 12 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A078560-001 | EZETIMIBE | GLENMARK PHARMACEUTICALS LTD | TABLET | ORAL | EZETIMIBE: 10MG | 2015/06/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078724-001 | EZETIMIBE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | DISCONTINUED | openFDA ↗ |
| A200831-001 | EZETIMIBE | WATSON LABORATORIES INC | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | DISCONTINUED | openFDA ↗ |
| A201790-001 | EZETIMIBE | RISING PHARMA HOLDING INC | TABLET | ORAL | EZETIMIBE: 10MG | 2019/04/26 | N / N | DISCONTINUED | openFDA ↗ |
| A203931-001 | EZETIMIBE | SANDOZ INC | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204331-001 | EZETIMIBE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207311-001 | EZETIMIBE | OHM LABORATORIES INC | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208332-001 | EZETIMIBE | APOTEX INC | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | DISCONTINUED | openFDA ↗ |
| A208803-001 | EZETIMIBE | AMNEAL PHARMACEUTICALS CO GMBH | TABLET | ORAL | EZETIMIBE: 10MG | 2017/06/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209234-001 | EZETIMIBE | ALKEM LABORATORIES LTD | TABLET | ORAL | EZETIMIBE: 10MG | 2017/12/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209838-001 | EZETIMIBE | AUROBINDO PHARMA LTD | TABLET | ORAL | EZETIMIBE: 10MG | 2017/08/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210673-001 | EZETIMIBE | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | EZETIMIBE: 10MG | 2020/10/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210859-001 | EZETIMIBE | HETERO LABS LTD UNIT III | TABLET | ORAL | EZETIMIBE: 10MG | 2022/07/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211159-001 | EZETIMIBE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | EZETIMIBE: 10MG | 2024/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A211550-001 | EZETIMIBE | ACCORD HEALTHCARE INC | TABLET | ORAL | EZETIMIBE: 10MG | 2018/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215693-001 | EZETIMIBE | ORIENT PHARMA CO LTD | TABLET | ORAL | EZETIMIBE: 10MG | 2022/09/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021445-001 | ZETIA | ORGANON LLC A SUB OF ORGANON AND CO | TABLET | ORAL | EZETIMIBE: 10MG | 2002/10/25 | 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 expiration2026/04/30This latest date comes from a *PED row in the source and is displayed as listed.
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 |
|---|---|---|---|---|---|---|
| N021445-001 | 7612058 | 2025/10/30 | — / — | U-1027 | — | openFDA ↗ |
| N021445-001 | 7612058*PED | 2026/04/30 | — / — | — | — | openFDA ↗ |
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 21
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2026556410mg | 2026/08/04 | Official source ↗ |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized | 国药准字H2026439610mg | 2026/05/19 | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2026423710mg | 2026/05/07 | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ2026003410mg | 2026/04/14 | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H2026345910mg | 2026/02/25 | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H2025613910mg | 2025/12/03 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2025316210mg | 2025/01/14 | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | 2024/12/25 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | 2024/12/17 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | 2024/12/01 | Official source ↗ |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H2024917110mg | 2024/10/22 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2024406710mg | 2024/06/18 | Official source ↗ |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | 国药准字H2024376210mg | 2024/05/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | 2024/02/23 | Official source ↗ |
| Nanjing Hai Jing Pharma Co., Ltd. romanized | 国药准字H2023316410mg | 2023/02/14 | Official source ↗ |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2021376010mg | 2021/09/30 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2021358410mg | 2021/07/20 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2021358510mg | 2021/07/20 | Official source ↗ |
| Sandoz Inc. | 国药准字HJ2021005010mg | 2021/06/29 | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | 2020/09/08 | Official source ↗ |
| MSD Pharma (Singapore) Pte. Ltd. | H2016018110mg | 2006/04/06 | Official source ↗ |
NHSA approval numbers 23
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2026423710mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2021358410mg | — | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2024406710mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H2021376010mg | — | Official source ↗ |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2023316410mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J2017102310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2026556410mg | — | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H2026345910mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized | 国药准字H2026439610mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2021358510mg | — | Official source ↗ |
| MSD International GmbH (Singapore Branch) | H2016018110mg | — | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ2026003410mg | — | Official source ↗ |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | 国药准字H2024376210mg | — | Official source ↗ |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H2024917110mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2025316210mg | — | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H2025613910mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Sandoz Inc. | 国药准字HJ2021005010mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2026423710mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2021358410mg | — | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2024406710mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H2021376010mg | — | Official source ↗ |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2023316410mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J2017102310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2021358510mg | — | Official source ↗ |
| MSD International GmbH (Singapore Branch) | H2016018110mg | — | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ2026003410mg | — | Official source ↗ |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H2024917110mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2025316210mg | — | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H2025613910mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Sandoz Inc. | 国药准字HJ2021005010mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2026423710mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2021358410mg | — | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2024406710mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H2021376010mg | — | Official source ↗ |
| Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2023316410mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J2017102310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2021358510mg | — | Official source ↗ |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ2016018110mg | — | Official source ↗ |
| Beijing Bai Ao Pharma Co., Ltd. romanized | 国药准字H2024917110mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2025316210mg | — | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized | 国药准字H2025613910mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Sandoz Inc. | 国药准字HJ2021005010mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2021358410mg | — | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2024406710mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H2021376010mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2021358510mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2025316210mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2021358410mg | — | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2024406710mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H2021376010mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ2016018110mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ2016018110mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H2024981810mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H2024973710mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2024949810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2020346810mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2024325310mg | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601395 | 2026/06/12 | Official source ↗ |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | CYHS2602544 | 2026/10/14 | Official source ↗ |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2504117 | 2025/12/02 | Official source ↗ |
| Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | CYHS2602594 | 2026/10/22 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601395 | 2026/06/12 | Official source ↗ |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | CYHS2602544 | 2026/10/14 | Official source ↗ |
| Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | CYHS2602594 | 2026/10/22 | Official source ↗ |
API companies with A status 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000047 | 2026/07/20 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20240001567 | 2026/07/14 | Official source ↗ |
| Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20230001252 | 2025/07/11 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20230000515 | 2024/09/02 | Official source ↗ |
| Apitoria Pharma Private Limited | Y20230000079 | 2025/01/06 | Official source ↗ |
| Hetero Labs Limited | Y20220000766 | 2026/03/19 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | Y20220000666 | 2026/02/10 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20210000966 | 2023/08/29 | Official source ↗ |
| Hanmi Fine Chemical Co., Ltd. | Y20200001433 | 2024/10/24 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20210000182 | 2022/11/02 | Official source ↗ |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Y20210000199 | 2023/02/21 | Official source ↗ |
| LUPIN LIMITED | Y20210000140 | 2025/05/17 | Official source ↗ |
| Shandong Bo Yuan Pharma Co., Ltd. romanized | Y20200001270 | 2024/02/27 | Official source ↗ |
| Synthimed Labs Private Limited | Y20200001218 | 2026/07/17 | Official source ↗ |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20200000290 | 2022/10/27 | Official source ↗ |
| Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20190000721 | 2026/01/06 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190000874 | 2026/04/30 | Official source ↗ |
| TEVA API INDIA PRIVATE LIMITED | Y20190000329 | 2026/07/15 | Official source ↗ |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | Y20190000024 | 2025/09/16 | Official source ↗ |
| MSN Laboratories Private Limited Yi De Pharma (Shanghai) Co., Ltd. romanized | Y20180001083 | 2025/07/30 | 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 ↗ · 44-49 · 2021/08/23
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