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Matched- Active ingredients (original)
- BISOPROLOL FUMARATE
- 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 approval1992/07/31
ANDA applications13
RLD applicantTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC
Currently marketed products: 23 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A075474-001 | BISOPROLOL FUMARATE | TP ANDA HOLDINGS LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2002/10/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075474-002 | BISOPROLOL FUMARATE | TP ANDA HOLDINGS LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2002/10/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075643-001 | BISOPROLOL FUMARATE | RUBICON RESEARCH LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2000/11/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075643-002 | BISOPROLOL FUMARATE | RUBICON RESEARCH LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2000/11/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075643-003 | BISOPROLOL FUMARATE | RUBICON RESEARCH LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 2.5MG | 2025/03/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075644-001 | BISOPROLOL FUMARATE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2001/06/26 | N / N | DISCONTINUED | openFDA ↗ |
| A075644-002 | BISOPROLOL FUMARATE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2001/06/26 | N / N | DISCONTINUED | openFDA ↗ |
| A075831-001 | BISOPROLOL FUMARATE | NATCO PHARMA USA LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2005/12/14 | N / N | DISCONTINUED | openFDA ↗ |
| A075831-002 | BISOPROLOL FUMARATE | NATCO PHARMA USA LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2005/12/14 | N / N | DISCONTINUED | openFDA ↗ |
| A077910-001 | BISOPROLOL FUMARATE | AUROBINDO PHARMA LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2006/12/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077910-002 | BISOPROLOL FUMARATE | AUROBINDO PHARMA LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2006/12/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078635-001 | BISOPROLOL FUMARATE | UNICHEM LABORATORIES LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2009/08/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078635-002 | BISOPROLOL FUMARATE | UNICHEM LABORATORIES LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2009/08/18 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204891-001 | BISOPROLOL FUMARATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2017/01/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204891-002 | BISOPROLOL FUMARATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2017/01/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215563-001 | BISOPROLOL FUMARATE | NOVITIUM PHARMA LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2021/10/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215563-002 | BISOPROLOL FUMARATE | NOVITIUM PHARMA LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2021/10/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215680-001 | BISOPROLOL FUMARATE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2022/07/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215680-002 | BISOPROLOL FUMARATE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2022/07/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217368-001 | BISOPROLOL FUMARATE | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2023/07/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217368-002 | BISOPROLOL FUMARATE | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2023/07/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217617-001 | BISOPROLOL FUMARATE | HARMAN FINOCHEM LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2024/01/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217617-002 | BISOPROLOL FUMARATE | HARMAN FINOCHEM LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2024/01/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218303-001 | BISOPROLOL FUMARATE | MICRO LABS LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2026/03/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218303-002 | BISOPROLOL FUMARATE | MICRO LABS LTD | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2026/03/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219044-001 | BISOPROLOL FUMARATE | UNIQUE PHARMACEUTICAL LABORATORIES | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG | 2025/04/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219044-002 | BISOPROLOL FUMARATE | UNIQUE PHARMACEUTICAL LABORATORIES | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG | 2025/04/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019982-001 | ZEBETA | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1992/07/31 | Y / N | DISCONTINUED | openFDA ↗ |
| N019982-002 | ZEBETA | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC | TABLET | ORAL | BISOPROLOL FUMARATE: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1992/07/31 | 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 17
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643412.5mg | 2026/05/19 | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643405mg | 2026/05/19 | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638455mg | 2026/04/07 | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638442.5mg | 2026/04/07 | Official source ↗ |
| Shanghai Jian Hui Le Xiang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630065mg | 2026/01/05 | Official source ↗ |
| Shanghai Jian Hui Le Xiang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630052.5mg | 2026/01/05 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558772.5mg | 2025/11/04 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558765mg | 2025/11/04 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | 2025/09/30 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | 2025/09/30 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543415mg | 2025/05/27 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543402.5mg | 2025/05/27 | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | 2025/04/15 | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539392.5mg | 2025/04/15 | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H202530125mg | 2025/01/02 | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H202530132.5mg | 2025/01/02 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | 2024/09/03 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | 2024/09/03 | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439475mg | 2024/06/04 | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439462.5mg | 2024/06/04 | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | 2024/03/19 | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | 2024/01/09 | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430102.5mg | 2024/01/09 | Official source ↗ |
| Hexal AG | 国药准字HJ201702615mg | 2023/04/28 | Official source ↗ |
| Hexal AG | 国药准字HJ201702595mg | 2023/03/22 | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | 2020/05/22 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830072.5mg | 2020/01/07 | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H200231322.5mg | 2019/06/21 | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H109700825mg | 2019/06/21 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830085mg | 2018/07/20 | Official source ↗ |
| Merck Serono GmbH | H201604752.5mg | 2005/09/15 | Official source ↗ |
| Merck Serono GmbH | H201604745mg | 1995/06/08 | Official source ↗ |
NHSA approval numbers 32
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H200231322.5mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830072.5mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558765mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H202530125mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439462.5mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539392.5mg | — | Official source ↗ |
| Hexal AG | 国药准字HJ201702595mg | — | Official source ↗ |
| Merck Serono GmbH | H201604752.5mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638455mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643405mg | — | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H200231322.5mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830072.5mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558765mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439462.5mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539392.5mg | — | Official source ↗ |
| Salutas Pharma GmbH | 国药准字J201710435mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638455mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830072.5mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558765mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439462.5mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539392.5mg | — | Official source ↗ |
| Lek.S.A. | 国药准字HJ201702615mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638455mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558765mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439462.5mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | — | Official source ↗ |
| Hexal AG | 国药准字HJ201702595mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638455mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558765mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543402.5mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | — | Official source ↗ |
| Lek.S.A. | 国药准字HJ201702615mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556405mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543402.5mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H201730375mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H202433485mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543402.5mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447932.5mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543402.5mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430095mg | — | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H109700825mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830085mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558772.5mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H202530132.5mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439475mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | — | Official source ↗ |
| Merck Healthcare Germany GmbH | 国药准字HJ201604745mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638442.5mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430102.5mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643405mg | — | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H109700825mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830085mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558772.5mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439475mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638442.5mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430102.5mg | — | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | 国药准字H109700825mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830085mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558772.5mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439475mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638442.5mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430102.5mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H200830085mg | — | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202558772.5mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H202439475mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202638442.5mg | — | Official source ↗ |
| Zhejiang Xiong Di Pharma Co., Ltd. romanized | 国药准字H202430102.5mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543415mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202556412.5mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543415mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H202539405mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543415mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H202543415mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H202447945mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643405mg | — | Official source ↗ |
| Mo Ke Pharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H202050065mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643405mg | — | Official source ↗ |
| Mo Ke Pharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H202050065mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643412.5mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643412.5mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643412.5mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643412.5mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643405mg | — | Official source ↗ |
| Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643412.5mg | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHB2601921 | 2026/10/21 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHB2601920 | 2026/10/21 | Official source ↗ |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601728 | 2026/07/20 | Official source ↗ |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601727 | 2026/07/20 | Official source ↗ |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600046 | 2026/01/06 | Official source ↗ |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600045 | 2026/01/06 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601728 | 2026/07/20 | Official source ↗ |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CYHS2601727 | 2026/07/20 | Official source ↗ |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600046 | 2026/01/06 | Official source ↗ |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | CYHS2600045 | 2026/01/06 | Official source ↗ |
API companies with A status 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| UNICHEM LABORATORIES LIMITED | Y20200000629 | 2023/02/08 | Official source ↗ |
| Xin Dong Sheng Ji Co., Ltd. romanized | Y20190021601 | 2024/05/17 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20190006118 | 2025/07/10 | Official source ↗ |
| Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | Y20190005788 | 2026/09/29 | Official source ↗ |
| Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20190005732 | 2025/12/17 | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | Y20190004497 | 2024/01/17 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20190001402 | 2024/07/18 | Official source ↗ |
| Taiwan Biotech Co.,Ltd. | Y20170001503 | 2026/01/14 | Official source ↗ |
| Ipca Laboratories Limited | Y20170001028 | 2026/04/28 | Official source ↗ |
| Merck KGaA | Y20170000769 | 2025/10/19 | 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 ↗ · 34-15 · 2020/12/21
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