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Matched- Active ingredients (original)
- FUROSEMIDE
- 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 approvalApproved before 1982
ANDA applications27
RLD applicantAMERICAN REGENT INC / SANOFI AVENTIS US LLC
Currently marketed products: 17 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A070014-001 | FUROSEMIDE | ASTRAZENECA LP | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1985/09/09 | N / N | DISCONTINUED | openFDA ↗ |
| A070017-001 | FUROSEMIDE | ACCORD HEALTHCARE INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1986/12/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A070019-001 | FUROSEMIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1986/09/22 | N / N | DISCONTINUED | openFDA ↗ |
| A070023-001 | FUROSEMIDE | SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1986/02/05 | N / N | DISCONTINUED | openFDA ↗ |
| A070078-001 | FUROSEMIDE | SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1986/02/05 | N / N | DISCONTINUED | openFDA ↗ |
| A070095-001 | FUROSEMIDE | IGI LABORATORIES INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1985/09/09 | N / N | DISCONTINUED | openFDA ↗ |
| A070096-001 | FUROSEMIDE | IGI LABORATORIES INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1985/09/09 | N / N | DISCONTINUED | openFDA ↗ |
| A070578-001 | FUROSEMIDE | HOSPIRA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1987/07/08 | N / N | DISCONTINUED | openFDA ↗ |
| A070604-001 | FUROSEMIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1987/01/02 | N / N | DISCONTINUED | openFDA ↗ |
| A071439-001 | FUROSEMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1990/09/14 | N / N | DISCONTINUED | openFDA ↗ |
| A072080-001 | FUROSEMIDE | HOSPIRA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1991/08/13 | N / N | DISCONTINUED | openFDA ↗ |
| A074017-001 | FUROSEMIDE | MARSAM PHARMACEUTICALS LLC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1994/06/30 | N / N | DISCONTINUED | openFDA ↗ |
| A074337-001 | FUROSEMIDE | HOSPIRA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1994/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A075241-001 | FUROSEMIDE | HOSPIRA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1999/05/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077941-001 | FUROSEMIDE | APOTEX INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2007/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202747-001 | FUROSEMIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2014/01/27 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203428-001 | FUROSEMIDE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2014/08/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207552-001 | FUROSEMIDE | AMNEAL PHARMACEUTICALS CO GMBH | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2016/07/20 | N / N | DISCONTINUED | openFDA ↗ |
| A208435-001 | FUROSEMIDE | AREVA PHARMACEUTICALS INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2020/12/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212174-001 | FUROSEMIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2019/05/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212803-001 | FUROSEMIDE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2022/01/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213902-001 | FUROSEMIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2020/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214766-001 | FUROSEMIDE | SAGENT PHARMACEUTICALS | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2021/01/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215856-001 | FUROSEMIDE | SABA ILAC SANAYIVE TICARET AS | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2024/04/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216860-001 | FUROSEMIDE | MANKIND PHARMA LTD | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2022/12/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217557-001 | FUROSEMIDE | ASPIRO PHARMA LTD | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2024/12/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218188-001 | FUROSEMIDE | MICRO LABS LTD | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 2026/01/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N016363-001 | LASIX | SANOFI AVENTIS US LLC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N018025-001 | FUROSEMIDE | INTERNATIONAL MEDICATION SYSTEM | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N018267-001 | FUROSEMIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | Approved before 1982 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018420-001 | FUROSEMIDE | WARNER CHILCOTT DIV WARNER LAMBERT CO | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1982/02/26 | N / N | DISCONTINUED | openFDA ↗ |
| N018507-001 | FUROSEMIDE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1982/07/30 | N / N | DISCONTINUED | openFDA ↗ |
| N018579-001 | FUROSEMIDE | AMERICAN REGENT INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1983/11/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N018667-001 | FUROSEMIDE | HOSPIRA INC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1982/05/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018670-001 | FUROSEMIDE | WYETH AYERST LABORATORIES | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1982/07/20 | N / N | DISCONTINUED | openFDA ↗ |
| N018902-001 | FUROSEMIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1984/05/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019036-001 | FUROSEMIDE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | FUROSEMIDE: 10MG/ML | 1984/08/13 | N / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 27
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized | 国药准字H200451642ml:20mg | 2026/03/09 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202634342ml：20mg | 2026/02/25 | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H202631442ml：20mg | 2026/01/20 | Official source ↗ |
| Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 国药准字H202535552ml：20mg | 2025/03/04 | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H202497702ml：20mg | 2024/12/25 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H130200212ml：20mg | 2024/12/20 | Official source ↗ |
| Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized | 国药准字H140226272ml:20mg | 2024/12/09 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H130210342ml:20mg | 2024/12/05 | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H202495872ml:20mg | 2024/12/01 | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H2024958610ml:100mg | 2024/12/01 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410210562ml：20mg | 2024/11/12 | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2024440610ml:100mg | 2024/07/09 | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H202438382ml:20mg | 2024/05/28 | Official source ↗ |
| Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H340219842ml：20mg | 2024/01/04 | Official source ↗ |
| Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | 国药准字H202338962ml:20mg | 2023/06/30 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2023706410ml：100mg | 2023/06/14 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H320215272ml：20mg | 2023/06/14 | Official source ↗ |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202332762ml:20mg | 2023/03/15 | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202331042ml:20mg | 2023/01/31 | Official source ↗ |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H202330482ml:20mg | 2023/01/10 | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202238982ml:20mg | 2022/11/30 | Official source ↗ |
| Hubei Tian Sheng Pharma Co., Ltd. romanized | 国药准字H420204172ml:20mg | 2022/11/11 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310210632ml：20mg | 2022/10/09 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H370202932ml：20mg | 2022/10/08 | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H310210752ml：20mg | 2022/03/09 | Official source ↗ |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | 国药准字H410203102ml：20mg | 2022/02/22 | Official source ↗ |
| Tianjin Jin Yao Pharma Co., Ltd. romanized | 国药准字H120205272ml:20mg | 2022/01/12 | Official source ↗ |
| Tianjin Jin Yao Group Hubei Tian Yao Pharma Co., Ltd. romanized | 国药准字H420200342ml：20mg | 2021/12/21 | Official source ↗ |
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H202139202ml:20mg | 2021/12/08 | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H202444052ml:20mg | 2024/07/09 | Official source ↗ |
NHSA approval numbers 57
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H440225062ml:20mg | — | Official source ↗ |
| Guangdong Xin Feng Pharma Co., Ltd. romanized | 国药准字H440220032ml:20mg | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H310210752ml:20mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310210632ml:20mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H120205272ml:20mg | — | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H202438382ml:20mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500201012ml:20mg | — | Official source ↗ |
| Jiangsu Yue Xing Pharma Co., Ltd. romanized | 国药准字H320200642ml:20mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H320215272ml:20mg | — | Official source ↗ |
| Jiangsu Lang Ou Pharma Co., Ltd. romanized | 国药准字H320210672ml:20mg | — | Official source ↗ |
| Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 国药准字H420230052ml:20mg | — | Official source ↗ |
| Hubei Tian Sheng Pharma Co., Ltd. romanized | 国药准字H420204172ml:20mg | — | Official source ↗ |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H420200342ml:20mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H202495872ml:20mg | — | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H420220752ml:20mg | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2023706410ml:100mg | — | Official source ↗ |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H510231392ml：20mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H510231582ml:20mg | — | Official source ↗ |
| Xian Feng Hua Pharma Co., Ltd. romanized | 国药准字H610211242ml:20mg | — | Official source ↗ |
| Xian Di Sai Bio Pharma Co., Ltd. romanized | 国药准字H610211392ml:20mg | — | Official source ↗ |
| Hebei Wu Luo Pharma Co., Ltd. romanized | 国药准字H130214272ml:20mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H130200212ml:20mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H130210342ml:20mg | — | Official source ↗ |
| Shanxi Guo Run Pharmaceutical Co., Ltd. romanized | 国药准字H140206502ml:20mg | — | Official source ↗ |
| Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized | 国药准字H140226272ml:20mg | — | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H200558612ml:20mg | — | Official source ↗ |
| Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized | 国药准字H200451642ml:20mg | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H410217942ml:20mg | — | Official source ↗ |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | 国药准字H410203102ml:20mg | — | Official source ↗ |
| Chang Bai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H220246992ml:20mg | — | Official source ↗ |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H200539492ml:20mg | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H202497702ml:20mg | — | Official source ↗ |
| Heilongjiang Sheng Ge Run Pharma Co., Ltd. romanized | 国药准字H230223502ml:20mg | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H370210562ml:20mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H370202932ml:20mg | — | Official source ↗ |
| Shandong Yi Jian Pharma Co., Ltd. romanized | 国药准字H200588762ml:20mg | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H370212082ml:20mg | — | Official source ↗ |
| Xu Chang Wei Lai Pharmaceutical Co., Ltd. romanized | 国药准字H340207742ml:20mg | — | Official source ↗ |
| Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H340219842ml:20mg | — | Official source ↗ |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H202330482ml:20mg | — | Official source ↗ |
| Fujian Nan Shao Lin Pharma Co., Ltd. romanized | 国药准字H350200282ml:20mg | — | Official source ↗ |
| Yunnan Bai Yao Group Co., Ltd. romanized | 国药准字H530200332ml:20mg | — | Official source ↗ |
| Gansu Lan Yao Pharma Co., Ltd. romanized | 国药准字H620207172ml:20mg | — | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H202631442ml:20mg | — | Official source ↗ |
| Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | 国药准字H202338962ml:20mg | — | Official source ↗ |
| Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized | 国药准字H202139202ml:20mg | — | Official source ↗ |
| Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized | 国药准字H202238982ml:20mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H202444052ml:20mg | — | Official source ↗ |
| Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202332762ml:20mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202331042ml:20mg | — | Official source ↗ |
| Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 国药准字H202535552ml:20mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202634342ml:20mg | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H440225062ml:20mg | — | Official source ↗ |
| Guangdong Xin Feng Pharma Co., Ltd. romanized | 国药准字H440220032ml:20mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310210632ml:20mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500201012ml:20mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H320215272ml:20mg | — | Official source ↗ |
| Jiangsu Lang Ou Pharma Co., Ltd. romanized | 国药准字H320210672ml:20mg | — | Official source ↗ |
| Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 国药准字H420230052ml:20mg | — | Official source ↗ |
| Hubei Jin Yao Pharma Co., Ltd. romanized | 国药准字H420200342ml:20mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H202495872ml:20mg | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2023706410ml:100mg | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H510231582ml:20mg | — | Official source ↗ |
| Xian Feng Hua Pharma Co., Ltd. romanized | 国药准字H610211242ml:20mg | — | Official source ↗ |
| Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized | 国药准字H610216802ml:20mg | — | Official source ↗ |
| Hebei Wu Luo Pharma Co., Ltd. romanized | 国药准字H130214272ml:20mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H130200212ml:20mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H130210342ml:20mg | — | Official source ↗ |
| Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized | 国药准字H140226272ml:20mg | — | Official source ↗ |
| Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized | 国药准字H200451642ml:20mg | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H410217942ml:20mg | — | Official source ↗ |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | 国药准字H410203102ml:20mg | — | Official source ↗ |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H200539492ml:20mg | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H202497702ml:20mg | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | 国药准字H370210562ml:20mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H370202932ml:20mg | — | Official source ↗ |
| Shandong Yi Jian Pharma Co., Ltd. romanized | 国药准字H200588762ml:20mg | — | Official source ↗ |
| Xu Chang Wei Lai Pharmaceutical Co., Ltd. romanized | 国药准字H340207742ml:20mg | — | Official source ↗ |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H202330482ml:20mg | — | Official source ↗ |
| Fujian Nan Shao Lin Pharma Co., Ltd. romanized | 国药准字H350200282ml:20mg | — | Official source ↗ |
| Gansu Lan Yao Pharma Co., Ltd. romanized | 国药准字H620207172ml:20mg | — | Official source ↗ |
| Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | 国药准字H202338962ml:20mg | — | Official source ↗ |
| Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized | 国药准字H202238982ml:20mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H202444052ml:20mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202331042ml:20mg | — | Official source ↗ |
| Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 国药准字H202535552ml:20mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202634342ml:20mg | — | Official source ↗ |
| Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized | 国药准字H610216802ml:20mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410210562ml:20mg | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H202497702ml:20mg | — | Official source ↗ |
| Fujian Nan Shao Lin Pharma Co., Ltd. romanized | 国药准字H350200282ml:20mg | — | Official source ↗ |
| Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | 国药准字H202338962ml:20mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H202444052ml:20mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410210562ml:20mg | — | Official source ↗ |
| Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized | 国药准字H610216802ml:20mg | — | Official source ↗ |
| Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized | 国药准字H610216802ml:20mg | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H310210752ml:20mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H120205272ml:20mg | — | Official source ↗ |
| Hubei Tian Sheng Pharma Co., Ltd. romanized | 国药准字H420204172ml:20mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H2024958610ml:100mg | — | Official source ↗ |
| Shanxi Guo Run Pharmaceutical Co., Ltd. romanized | 国药准字H140206502ml:20mg | — | Official source ↗ |
| Jilin Sheng Ji An Yi Sheng Pharma Co., Ltd. romanized | 国药准字H220215002ml:20mg | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H370212082ml:20mg | — | Official source ↗ |
| Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H340219842ml:20mg | — | Official source ↗ |
| Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized | 国药准字H202139202ml:20mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2024440610ml:100mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H2024958610ml:100mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2024440610ml:100mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2024440610ml:100mg | — | Official source ↗ |
| Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202332762ml:20mg | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Shuang He Pharma Co., Ltd. romanized | CYHS2602123 | 2026/08/26 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceutical Co., Ltd. romanized | CYHS2601301 | 2026/06/04 | Official source ↗ |
| Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized | CYHS2600651 | 2026/03/12 | Official source ↗ |
| Shandong Yi Jian Pharma Co., Ltd. romanized | CYHB2550377 | 2025/12/02 | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | CYHS2503622 | 2025/10/11 | Official source ↗ |
| Henan Pu Rui Pharma Co., Ltd. romanized | CYHS2503598 | 2025/10/09 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Shuang He Pharma Co., Ltd. romanized | CYHS2602123 | 2026/08/26 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceutical Co., Ltd. romanized | CYHS2601301 | 2026/06/04 | Official source ↗ |
| Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized | CYHS2600651 | 2026/03/12 | Official source ↗ |
API companies with A status 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Huang Shi Fu Er Tai Pharmaceuticals Technology Co., Ltd. romanized | Y20250000155 | 2026/07/14 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000026 | 2026/06/11 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20240001396 | 2026/06/11 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240001516 | 2026/07/21 | Official source ↗ |
| SRI KRISHNA PHARMACEUTICALS LIMITED UNIT IV | Y20230001118 | 2026/07/21 | Official source ↗ |
| Sichuan Sheng Yu Xin Pharma Co., Ltd. romanized | Y20240000125 | 2025/07/28 | Official source ↗ |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | Y20230000311 | 2026/10/21 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | Y20230000252 | 2024/06/12 | Official source ↗ |
| Hunan Ou Ya Pharma Co., Ltd. romanized | Y20220000566 | 2026/04/08 | Official source ↗ |
| Henan Jing Kang Pharmaceutical Co., Ltd. romanized | Y20220000320 | 2024/09/20 | Official source ↗ |
| Mangalam Drugs and Organics Ltd. | Y20200000835 | 2026/10/15 | Official source ↗ |
| Assia Chemical Industries Ltd. | Y20200001166 | 2025/05/17 | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | Y20219990005 | — | Official source ↗ |
| Curia India Private Limited | Y20190009097 | 2025/06/03 | Official source ↗ |
| Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190008722 | 2025/07/24 | Official source ↗ |
| Beijing Tai Yang Pharma Co., Ltd. romanized | Y20190005487 | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20190003799 | 2024/04/24 | Official source ↗ |
| Tai Shan Shi Xin Ning Pharmaceutical Co., Ltd. romanized | Y20190002797 | 2026/02/27 | Official source ↗ |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | Y20190002195 | 2023/04/23 | Official source ↗ |
| Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanized | Y20190002139 | 2026/03/04 | Official source ↗ |
| Ipca Laboratories Limited | Y20170000088 | 2024/06/27 | 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 ↗ · 24-72 · 2020/01/03
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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