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Matched- Active ingredients (original)
- NOREPINEPHRINE BITARTRATE
- 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 applications20
RLD applicantHOSPIRA INC
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 |
|---|---|---|---|---|---|---|---|---|---|
| A040455-001 | NOREPINEPHRINE BITARTRATE | MEITHEAL PHARMACEUTICALS INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2003/03/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040462-001 | NOREPINEPHRINE BITARTRATE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2003/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040522-001 | NOREPINEPHRINE BITARTRATE | METRICS PHARMACEUTICAL VENTURES LLC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2004/09/30 | N / N | DISCONTINUED | openFDA ↗ |
| A040859-001 | NOREPINEPHRINE BITARTRATE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2012/03/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203662-001 | NOREPINEPHRINE BITARTRATE | HIKMA FARMACEUTICA PORTUGAL SA | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2018/11/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210839-001 | NOREPINEPHRINE BITARTRATE | AMNEAL EU LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2018/12/17 | N / N | DISCONTINUED | openFDA ↗ |
| A211242-001 | NOREPINEPHRINE BITARTRATE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2018/10/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211359-001 | NOREPINEPHRINE BITARTRATE | SANDOZ INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2018/10/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211382-001 | NOREPINEPHRINE BITARTRATE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2020/11/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211980-001 | NOREPINEPHRINE BITARTRATE | SUN PHARMACEUTICAL INDUSTRIES LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2021/01/29 | N / N | DISCONTINUED | openFDA ↗ |
| A214323-001 | NOREPINEPHRINE BITARTRATE | GLAND PHARMA LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2021/05/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214455-001 | NOREPINEPHRINE BITARTRATE | BRECKENRIDGE PHARMACEUTICAL INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2021/01/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216272-001 | NOREPINEPHRINE BITARTRATE | NEPHRON PHARMACEUTICALS CORPORATION | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2026/06/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216341-001 | NOREPINEPHRINE BITARTRATE | ZYDUS PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2022/07/19 | N / N | DISCONTINUED | openFDA ↗ |
| A217575-001 | NOREPINEPHRINE BITARTRATE | CAPLIN STERILES LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2023/09/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218595-001 | NOREPINEPHRINE BITARTRATE | MSN LABORATORIES PRIVATE LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2025/12/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218758-001 | NOREPINEPHRINE BITARTRATE | RISING PHARMA HOLDINGS INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2024/05/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219163-001 | NOREPINEPHRINE BITARTRATE | ASPIRO PHARMA LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2025/01/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219443-001 | NOREPINEPHRINE BITARTRATE | BIOCON PHARMA LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2025/03/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219924-001 | NOREPINEPHRINE BITARTRATE | ADAPTIS PHARMA PRIVATE LTD | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | 2025/11/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N007513-001 | LEVOPHED | HOSPIRA INC | INJECTABLE | INJECTION | NOREPINEPHRINE BITARTRATE: EQ 1MG BASE/ML | Approved before 1982 | 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 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 34
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202660501ml:2mg | 2026/09/22 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202660514ml:8mg | 2026/09/22 | Official source ↗ |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | 国药准字H202659914ml：8mg | 2026/09/15 | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202656624ml:8mg | 2026/08/18 | Official source ↗ |
| Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized | 国药准字H440223961ml：2mg | 2026/08/17 | Official source ↗ |
| Zhejiang Shang Ke Biopharmaceuticals Co., Ltd. romanized | 国药准字H202652724ml：8mg | 2026/07/21 | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643324ml:8mg | 2026/05/12 | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643311ml:2mg | 2026/05/12 | Official source ↗ |
| Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 国药准字H202636434ml:8mg | 2026/03/17 | Official source ↗ |
| Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized | 国药准字H202630784ml:8mg | 2026/01/14 | Official source ↗ |
| Jin Zhou Ao Hong Pharma Co., Ltd. romanized | 国药准字H202631194ml：8mg | 2026/01/14 | Official source ↗ |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H202563864ml：8mg | 2025/12/22 | Official source ↗ |
| Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202561261ml:2mg | 2025/12/03 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202561324ml:8mg | 2025/12/03 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202561044ml:8mg | 2025/12/03 | Official source ↗ |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H610216661ml:2mg | 2025/10/31 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H202553194ml: 8mg | 2025/09/02 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H202551914ml：8mg | 2025/08/26 | Official source ↗ |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202551424ml:8mg | 2025/08/19 | Official source ↗ |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202551411ml:2mg | 2025/08/19 | Official source ↗ |
| Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202541924ml：8mg | 2025/05/20 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310211771ml:2mg | 2025/05/14 | Official source ↗ |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H202541581ml：2mg | 2025/05/13 | Official source ↗ |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H202541594ml：8mg | 2025/05/13 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H202540394ml:8mg | 2025/04/30 | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202580421ml：2mg | 2025/03/25 | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H202496764ml:8mg | 2024/12/01 | Official source ↗ |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H202493371ml:2mg | 2024/11/15 | Official source ↗ |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H202493384ml:8mg | 2024/11/15 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H202493344ml∶8mg | 2024/11/15 | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202449961ml：2mg | 2024/09/26 | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202448524ml：8mg | 2024/09/10 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244708See source | 2024/08/20 | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443364ml:8mg | 2024/06/28 | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443351ml:2mg | 2024/06/28 | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202433274ml:8mg | 2024/03/12 | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202433261ml:2mg | 2024/03/12 | Official source ↗ |
| Shanghai Bao Long Bio Technology Co., Ltd. romanized | 国药准字H202347384ml:8mg | 2023/12/29 | Official source ↗ |
| Chengdu Shuo De Pharma Co., Ltd. romanized | 国药准字H202343334ml:8mg | 2023/10/18 | Official source ↗ |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H202333074ml:8mg | 2023/03/21 | Official source ↗ |
| Tianjin Jin Yao Pharma Co., Ltd. romanized | 国药准字H120206211ml：2mg | 2021/10/22 | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H202170654ml:8mg | 2021/07/30 | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420213011ml:2mg | 2021/07/30 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H202470244ml：8mg | 2024/02/05 | Official source ↗ |
NHSA approval numbers 42
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized | 国药准字H440223961ml:2mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310211771ml:2mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120206211ml∶2mg | — | Official source ↗ |
| Jin Zhou Ao Hong Pharma Co., Ltd. romanized | 国药准字H202631194ml:8mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H202540394ml:8mg | — | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202449961ml∶2mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H202496764ml:8mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420213011ml:2mg | — | Official source ↗ |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H610216661ml:2mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202447084ml:8mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H202493344ml∶8mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202561044ml:8mg | — | Official source ↗ |
| Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 国药准字H202561261ml:2mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443351ml:2mg | — | Official source ↗ |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | 国药准字H202659914ml:8mg | — | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 国药准字H202553194ml: 8mg | — | Official source ↗ |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H202333074ml:8mg | — | Official source ↗ |
| Shanghai Bao Long Bio Technology Co., Ltd. romanized | 国药准字H202347384ml:8mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202433261ml:2mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202448524ml:8mg | — | Official source ↗ |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H202493371ml:2mg | — | Official source ↗ |
| Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202541924ml:8mg | — | Official source ↗ |
| Chengdu Shuo De Pharma Co., Ltd. romanized | 国药准字H202343334ml:8mg | — | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643311ml:2mg | — | Official source ↗ |
| Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 国药准字H202636434ml:8mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202561324ml:8mg | — | Official source ↗ |
| Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized | 国药准字H202562844ml:8mg | — | Official source ↗ |
| Zhejiang Shang Ke Biopharmaceuticals Co., Ltd. romanized | 国药准字H202652724ml:8mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized | 国药准字H440223961ml:2mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310211771ml:2mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120206211ml∶2mg | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H202540394ml:8mg | — | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202449961ml∶2mg | — | Official source ↗ |
| Wuhan Jiu An Pharma Co., Ltd. romanized | 国药准字H202496764ml:8mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420213011ml:2mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202447084ml:8mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H202493344ml∶8mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202561044ml:8mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443351ml:2mg | — | Official source ↗ |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | 国药准字H202659914ml:8mg | — | Official source ↗ |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H202333074ml:8mg | — | Official source ↗ |
| Shanghai Bao Long Bio Technology Co., Ltd. romanized | 国药准字H202347384ml:8mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202433261ml:2mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202448524ml:8mg | — | Official source ↗ |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H202493371ml:2mg | — | Official source ↗ |
| Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202541924ml:8mg | — | Official source ↗ |
| Chengdu Shuo De Pharma Co., Ltd. romanized | 国药准字H202343334ml:8mg | — | Official source ↗ |
| Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 国药准字H202636434ml:8mg | — | Official source ↗ |
| Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized | 国药准字H202562844ml:8mg | — | Official source ↗ |
| Zhejiang Shang Ke Biopharmaceuticals Co., Ltd. romanized | 国药准字H202652724ml:8mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310211771ml:2mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120206211ml∶2mg | — | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202449961ml∶2mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420213011ml:2mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443351ml:2mg | — | Official source ↗ |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H202333074ml:8mg | — | Official source ↗ |
| Shanghai Bao Long Bio Technology Co., Ltd. romanized | 国药准字H202347384ml:8mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202448524ml:8mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310211762ml:10mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H202170654ml:8mg | — | Official source ↗ |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H610216661ml:2mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H370206342ml:10mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443364ml:8mg | — | Official source ↗ |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H202471461ml: 2mg | — | Official source ↗ |
| Shanghai Bao Long Bio Technology Co., Ltd. romanized | 国药准字H202690121ml:2mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202433274ml:8mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202580421ml:2mg | — | Official source ↗ |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H202493384ml:8mg | — | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202643324ml:8mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H370206342ml:10mg | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H202443364ml:8mg | — | Official source ↗ |
| Shanghai Bao Long Bio Technology Co., Ltd. romanized | 国药准字H202690121ml:2mg | — | Official source ↗ |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H202433274ml:8mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H202170654ml:8mg | — | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202580421ml:2mg | — | Official source ↗ |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H202493384ml:8mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H202470244ml:8mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420220482ml:10mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H202470244ml:8mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420220482ml:10mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized | 国药准字H420220482ml:10mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202660501ml:2mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202660501ml:2mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202660514ml:8mg | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H202660514ml:8mg | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | CYHS2602391 | 2026/09/23 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHB2601445 | 2026/07/28 | Official source ↗ |
| Hebei Ke Yuan Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | CYHS2600955 | 2026/04/24 | Official source ↗ |
| Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2504204 | 2025/12/06 | Official source ↗ |
| Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2504203 | 2025/12/06 | Official source ↗ |
| Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized | CYHS2504126 | 2025/12/02 | Official source ↗ |
| Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized | CYHS2504125 | 2025/12/02 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2503325 | 2025/09/08 | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHS2502844 | 2025/08/06 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | CYHS2602391 | 2026/09/23 | Official source ↗ |
| Hebei Ke Yuan Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | CYHS2600955 | 2026/04/24 | Official source ↗ |
API companies with A status 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20240001074 | 2026/07/13 | Official source ↗ |
| Zhejiang Shang Tai Biopharmaceutical Co., Ltd. romanized | Y20240000586 | 2026/09/19 | Official source ↗ |
| Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20240000250 | 2025/10/22 | Official source ↗ |
| Jin Zhou Ao Hong Pharma Co., Ltd. romanized | Y20240000355 | 2026/11/05 | Official source ↗ |
| Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized | Y20240000258 | 2025/12/18 | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | Y20230000508 | 2025/02/12 | Official source ↗ |
| Anhui Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20230000869 | 2026/01/01 | Official source ↗ |
| Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Y20230000665 | 2025/08/02 | Official source ↗ |
| Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | Y20230000409 | 2024/11/29 | Official source ↗ |
| Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | Y20230000575 | 2025/02/07 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20220001319 | 2024/07/17 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20220001149 | 2025/05/20 | Official source ↗ |
| Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20220000836 | 2024/04/13 | Official source ↗ |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20220000724 | 2026/01/22 | Official source ↗ |
| Hubei Mei Lin Pharma Co., Ltd. romanized | Y20220000243 | 2024/02/29 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20210001069 | 2025/01/25 | Official source ↗ |
| Su Zhou Yi Fan Pharma Co., Ltd. romanized | Y20210000170 | 2024/05/21 | Official source ↗ |
| ChemPacific Corp | Y20200000850 | 2023/07/04 | Official source ↗ |
| Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized | Y20190009540 | 2025/06/17 | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20190006135 | 2025/11/04 | Official source ↗ |
| Cambrex Profarmaco Milano S.r.l. | Y20180000333 | 2024/08/07 | 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 ↗ · 25-72 · 2020/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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