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Matched- Active ingredients (original)
- BUMETANIDE
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
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 approval1983/02/28
ANDA applications11
RLD applicantVALIDUS PHARMACEUTICALS LLC
Currently marketed products: 8 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A074160-001 | BUMETANIDE | HOSPIRA INC | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 1997/10/30 | N / N | DISCONTINUED | openFDA ↗ |
| A074332-001 | BUMETANIDE | HOSPIRA INC | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 1994/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A074441-001 | BUMETANIDE | SAGENT PHARMACEUTICALS | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 1995/01/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074613-001 | BUMETANIDE | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 1997/11/18 | N / N | DISCONTINUED | openFDA ↗ |
| A079196-001 | BUMETANIDE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2008/04/30 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215364-001 | BUMETANIDE | MSN LABORATORIES PRIVATE LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2022/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216434-001 | BUMETANIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2022/05/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217153-001 | BUMETANIDE | LUPIN LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2024/09/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218746-001 | BUMETANIDE | ASPIRO PHARMA LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2025/02/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219116-001 | BUMETANIDE | QILU PHARMACEUTICAL HAINAN CO LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2024/09/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A220427-001 | BUMETANIDE | ADAPTIS PHARMA PRIVATE LTD | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML | 2026/02/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018226-001 | BUMEX | VALIDUS PHARMACEUTICALS LLC | INJECTABLE | INJECTION | BUMETANIDE: 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1983/02/28 | 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 39
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202662804ml：1mg | 2026/10/13 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H202659324ml:2mg | 2026/09/15 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H202659312ml:1mg | 2026/09/15 | Official source ↗ |
| Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized | 国药准字H202655964ml：2mg | 2026/08/04 | Official source ↗ |
| Jiangsu Kai Yuan Pharma Co., Ltd. romanized | 国药准字H202655974ml：2mg | 2026/08/04 | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H202654584ml:1mg | 2026/08/04 | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H202654572ml:0.5mg | 2026/08/04 | Official source ↗ |
| Yunnan Hua Pai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202655144ml：2mg | 2026/08/04 | Official source ↗ |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H200573762ml:0.5mg | 2026/07/30 | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H202652134ml：2mg | 2026/07/21 | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H330209802ml:0.5mg | 2026/06/26 | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647344ml：2mg | 2026/06/10 | Official source ↗ |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202691291ml∶0.5mg | 2026/06/02 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202645152ml：1mg | 2026/05/27 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202645142ml：0.5mg | 2026/05/27 | Official source ↗ |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202644791ml ： 0.5mg | 2026/05/19 | Official source ↗ |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202644784ml：2mg | 2026/05/19 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202644401ml：0.5mg | 2026/05/19 | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H202690951ml：0.5mg | 2026/04/21 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202639514ml：1mg | 2026/04/14 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202638854ml：1mg | 2026/04/07 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202638842ml：0.5mg | 2026/04/07 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H202690771ml：0.5mg | 2026/03/27 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202637232ml：1mg | 2026/03/25 | Official source ↗ |
| Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized | 国药准字H202634694ml：2mg | 2026/02/25 | Official source ↗ |
| Suzhou Lang Ke Bio Technology Co., Ltd. romanized | 国药准字H202631822ml：1mg | 2026/01/20 | Official source ↗ |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H202630654ml : 2mg | 2026/01/14 | Official source ↗ |
| Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630614ml：1mg | 2026/01/14 | Official source ↗ |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H202630661ml : 0.5mg | 2026/01/14 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202630111ml:0.5mg | 2026/01/05 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202630124ml:2mg | 2026/01/05 | Official source ↗ |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563014ml:2mg | 2025/12/16 | Official source ↗ |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563002ml：1mg | 2025/12/16 | Official source ↗ |
| Beijing Liu Huan Pharma Co., Ltd. romanized | 国药准字H202563114ml∶2mg | 2025/12/16 | Official source ↗ |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202562354ml:2mg | 2025/12/09 | Official source ↗ |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | 国药准字H202560324ml:2mg | 2025/11/25 | Official source ↗ |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H202560334ml∶2mg | 2025/11/25 | Official source ↗ |
| Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H202552754ml: 2mg | 2025/09/02 | Official source ↗ |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202553334ml:1mg | 2025/09/02 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H202550304ml:1mg | 2025/07/29 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202549212ml：1mg | 2025/07/22 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202549204ml：2mg | 2025/07/22 | Official source ↗ |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202544562ml∶0.5mg | 2025/06/03 | Official source ↗ |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202540364ml：2mg | 2025/04/30 | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H202536994ml：2mg | 2025/03/25 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202532334ml:1mg | 2025/01/24 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H202497474ml：2mg | 2024/12/17 | Official source ↗ |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202497284ml：2mg | 2024/12/10 | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202445494ml:1mg | 2024/07/30 | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H200572252ml:1mg | 2024/04/15 | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H202470661ml:0.5mg | 2024/04/15 | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H202641244ml:2mg | 2026/04/21 | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647352ml：1mg | 2026/06/10 | Official source ↗ |
| Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202662914ml：2mg | 2026/10/20 | Official source ↗ |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H202645694ml:1mg | 2026/05/27 | Official source ↗ |
NHSA approval numbers 57
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Shi Yong Kang Pharma Co., Ltd. romanized | 国药准字H110205872ml：0.5mg | — | Official source ↗ |
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H200668462ml:0.5mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310215232ml:0.5mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500214612ml:0.5mg | — | Official source ↗ |
| Liaoning Yu Huang Pharma Co., Ltd. romanized | 国药准字H200835002ml:1mg | — | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647344ml:2mg | — | Official source ↗ |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H200570232ml:0.5mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H420208942ml:0.5mg | — | Official source ↗ |
| Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized | 国药准字H202634694ml:2mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H202536994ml:2mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202532334ml:1mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202637232ml:1mg | — | Official source ↗ |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H200573762ml:0.5mg | — | Official source ↗ |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202562354ml:2mg | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H202497474ml: 2mg | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H202652134ml:2mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202639514ml:1mg | — | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H330209802ml:0.5mg | — | Official source ↗ |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | 国药准字H350204602ml:0.5mg | — | Official source ↗ |
| Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H450200762ml:0.5mg | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H450209602ml:0.5mg | — | Official source ↗ |
| Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 国药准字H200572482ml:0.5mg | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H202552754ml: 2mg | — | Official source ↗ |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H201630982ml:0.5mg | — | Official source ↗ |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H202560334ml∶2mg | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H202550304ml:1mg | — | Official source ↗ |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H202645694ml:1mg | — | Official source ↗ |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H202630654ml : 2mg | — | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H202641244ml:2mg | — | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202630111ml:0.5mg | — | Official source ↗ |
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202640714ml : 2mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202445494ml∶1mg | — | Official source ↗ |
| Suzhou Lang Ke Bio Technology Co., Ltd. romanized | 国药准字H202631822ml:1mg | — | Official source ↗ |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202540364ml:2mg | — | Official source ↗ |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202497284ml:2mg | — | Official source ↗ |
| Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630614ml : 1mg | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H202549212ml:1mg | — | Official source ↗ |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H202560364ml:2mg | — | Official source ↗ |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202644784ml:2mg | — | Official source ↗ |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202553334ml:1mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202645152ml:1mg | — | Official source ↗ |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563002ml:1mg | — | Official source ↗ |
| Beijing Liu Huan Pharma Co., Ltd. romanized | 国药准字H202563114ml:2mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202645142ml:0.5mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500214612ml:0.5mg | — | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647344ml:2mg | — | Official source ↗ |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H200570232ml:0.5mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H420208942ml:0.5mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H202536994ml:2mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202637232ml:1mg | — | Official source ↗ |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H200573762ml:0.5mg | — | Official source ↗ |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202562354ml:2mg | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H202497474ml: 2mg | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H202652134ml:2mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202639514ml:1mg | — | Official source ↗ |
| Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H450200762ml:0.5mg | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H450209602ml:0.5mg | — | Official source ↗ |
| Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 国药准字H200572482ml:0.5mg | — | Official source ↗ |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H201630982ml:0.5mg | — | Official source ↗ |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H202645694ml:1mg | — | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202630111ml:0.5mg | — | Official source ↗ |
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202640714ml : 2mg | — | Official source ↗ |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202540364ml:2mg | — | Official source ↗ |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202497284ml:2mg | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H202549212ml:1mg | — | Official source ↗ |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H202560364ml:2mg | — | Official source ↗ |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202553334ml:1mg | — | Official source ↗ |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202544562ml∶0.5mg | — | Official source ↗ |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | 国药准字H202560324ml:2mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202645152ml:1mg | — | Official source ↗ |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563002ml:1mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202645142ml:0.5mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500214612ml:0.5mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202637232ml:1mg | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H202652134ml:2mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202639514ml:1mg | — | Official source ↗ |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H201630982ml:0.5mg | — | Official source ↗ |
| Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202553334ml:1mg | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H202652134ml:2mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202639514ml:1mg | — | Official source ↗ |
| Liaoning Yu Huang Pharma Co., Ltd. romanized | 国药准字H200834992ml:0.5mg | — | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647352ml:1mg | — | Official source ↗ |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H200570232ml:0.5mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H202690951ml:0.5mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202644401ml:0.5mg | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H202690771ml:0.5mg | — | Official source ↗ |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | 国药准字H350204602ml:0.5mg | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H200572252ml:1mg | — | Official source ↗ |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H202630661ml : 0.5mg | — | Official source ↗ |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202691291ml:0.5mg | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H202549204ml:2mg | — | Official source ↗ |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202644791ml:0.5mg | — | Official source ↗ |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563014ml:2mg | — | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647352ml:1mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202644401ml:0.5mg | — | Official source ↗ |
| Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202691291ml:0.5mg | — | Official source ↗ |
| Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 国药准字H202549204ml:2mg | — | Official source ↗ |
| Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563014ml:2mg | — | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647352ml:1mg | — | Official source ↗ |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H200570232ml:0.5mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202644401ml:0.5mg | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H200572252ml:1mg | — | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H202647352ml:1mg | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H200572252ml:1mg | — | Official source ↗ |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | 国药准字H202560324ml:2mg | — | Official source ↗ |
Under review 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600530 | 2026/02/26 | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600529 | 2026/02/26 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601384 | 2026/06/11 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601382 | 2026/06/11 | Official source ↗ |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | CYHB2601065 | 2026/06/05 | Official source ↗ |
| Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601212 | 2026/05/29 | Official source ↗ |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | CYHB2650108 | 2026/04/30 | Official source ↗ |
| Shandong Yi Jian Pharma Co., Ltd. romanized | CYHS2503579 | 2025/09/30 | Official source ↗ |
| Shandong Yi Jian Pharma Co., Ltd. romanized | CYHS2503578 | 2025/09/30 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | CYHS2502591 | 2025/07/18 | Official source ↗ |
| Shandong Hui Cheng Pharma Co., Ltd. romanized | CYHS2501471 | 2025/04/17 | Official source ↗ |
| Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2501196 | 2025/03/27 | Official source ↗ |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | CYHS2403001 | 2024/09/11 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600530 | 2026/02/26 | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHS2600529 | 2026/02/26 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601384 | 2026/06/11 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2601382 | 2026/06/11 | Official source ↗ |
| Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601212 | 2026/05/29 | Official source ↗ |
API companies with A status 24
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20240000927 | 2026/07/13 | Official source ↗ |
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | Y20240001294 | 2026/05/07 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240001211 | 2026/07/15 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20240001076 | 2026/04/01 | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20240000859 | 2026/04/21 | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | Y20240000936 | 2026/07/01 | Official source ↗ |
| Hangzhou Ao Sai Nuo Bio Technology Co., Ltd. romanized | Y20240000761 | 2026/03/17 | Official source ↗ |
| Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20240000807 | 2026/01/08 | Official source ↗ |
| Shandong Chen Long Pharma Co., Ltd. romanized | Y20240000775 | 2026/06/23 | Official source ↗ |
| Suzhou Li Xin Pharmaceutical Co., Ltd. romanized | Y20240000515 | 2025/11/26 | Official source ↗ |
| OLON S.P.A. | Y20240000359 | 2025/12/05 | Official source ↗ |
| Zhejiang Hao Hua Pharmaceutical Co., Ltd. romanized | Y20240000188 | 2025/05/28 | Official source ↗ |
| Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20230001167 | 2025/07/01 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20230001090 | 2025/07/18 | Official source ↗ |
| INDUSTRIALE CHIMICA S.R.L. | Y20230000563 | 2026/09/13 | Official source ↗ |
| Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | Y20230000614 | 2024/11/07 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20230000354 | 2026/03/03 | Official source ↗ |
| Su Zhou Yi Fan Pharma Co., Ltd. romanized | Y20230000386 | 2025/06/07 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Y20230000272 | 2026/08/15 | Official source ↗ |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20220001296 | 2026/01/22 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190007367 | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | Y20190004090 | 2025/01/18 | Official source ↗ |
| Hainan Wu Ren Pharmaceutical Co., Ltd. romanized | Y20190002887 | 2024/09/05 | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | Y20190002459 | 2025/01/03 | 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.
Formulation crosswalk to INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-076. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 46-43 · 2021/10/21
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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