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Tranexamic Acid Injection

Matched
Active ingredients (original)
TRANEXAMIC ACID
Dosage form (original)
INJECTABLE
Route (original)
INJECTION

Read these limits

  1. US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
  2. The Orange Book lists holder-submitted patents and does not cover all related patents.
  3. “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.
  4. This page contains no sales or market-size data and cannot establish development value.
  5. 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 approval1986/12/30
ANDA applications18
RLD applicantPFIZER INC

Currently marketed products: 13 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.

Application / product numberBrand name (original)Applicant (original)Dosage form (original)Route (original)Strength (original)Earliest approvalRLD / RSMarketing status (original)Official source
A091596-001TRANEXAMIC ACIDFRESENIUS KABI USA LLCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2012/03/02N / NDISCONTINUEDopenFDA ↗
A091657-001TRANEXAMIC ACIDMYLAN INSTITUTIONAL LLCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2011/11/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A201580-001TRANEXAMIC ACIDPHARMOBEDIENT CONSULTING LLCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2013/06/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A201885-001TRANEXAMIC ACIDAMERICAN REGENT INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2011/08/10N / NDISCONTINUEDopenFDA ↗
A202373-001TRANEXAMIC ACIDEPIC PHARMA LLCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2011/11/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A202436-001TRANEXAMIC ACIDHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2014/02/11N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A202755-001TRANEXAMIC ACIDCHARTWELL RX SCIENCES LLCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2016/02/25N / NDISCONTINUEDopenFDA ↗
A203521-001TRANEXAMIC ACIDAVET LIFESCIENCES LTDINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2014/08/12N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205035-001TRANEXAMIC ACIDEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2016/01/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205228-001TRANEXAMIC ACIDZYDUS PHARMACEUTICALS USA INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2017/07/17N / NDISCONTINUEDopenFDA ↗
A206594-001TRANEXAMIC ACIDEPIC PHARMA LLCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2017/09/28N / NDISCONTINUEDopenFDA ↗
A206634-001TRANEXAMIC ACIDRISING PHARMA HOLDINGS INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2016/06/09N / NDISCONTINUEDopenFDA ↗
A206713-001TRANEXAMIC ACIDMICRO LABS LTDINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2017/06/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207239-001TRANEXAMIC ACIDGLAND PHARMA LTDINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2017/02/13N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208840-001TRANEXAMIC ACIDAMNEAL PHARMACEUTICALS CO GMBHINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2017/02/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A209860-001TRANEXAMIC ACIDAPOTEX INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2020/01/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212360-001TRANEXAMIC ACIDCAPLIN STERILES LTDINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2019/07/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212676-001TRANEXAMIC ACIDMILLA PHARMACEUTICALS INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML2019/07/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N019281-001CYKLOKAPRONPFIZER INCINJECTABLEINJECTIONTRANEXAMIC ACID: 100MG/ML1986/12/30Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗

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 numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
Not listed

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: —

Application / product numberExclusivity codeListed expirationOfficial 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 33

Company (original)Identifier (original)Source dateOfficial source
Hainan Ai Ke Pharmaceutical Co., Ltd. romanized国药准字H202634625ml:0.5g2026/02/25Official source ↗
Hainan Ai Ke Pharmaceutical Co., Ltd. romanized国药准字H202634615ml:0.25g2026/02/25Official source ↗
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202558005ml∶0.25g2025/10/28Official source ↗
Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized国药准字H310218565ml:0.25g2025/07/15Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H202580235ml:0.25g2025/03/05Official source ↗
Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized国药准字H2024963210ml:1.0g2024/12/01Official source ↗
Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized国药准字H202496315ml:0.5g2024/12/01Official source ↗
Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized国药准字H202496305ml:0.25g2024/12/01Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446815ml:0.5g2024/08/20Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446825ml:0.25g2024/08/20Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446832.5ml:0.25g2024/08/20Official source ↗
Henan Run Hong Pharmaceutical Co., Ltd. romanized国药准字H2024434010ml:1.0g2024/06/28Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H2024424710ml:1.0g2024/06/28Official source ↗
Henan Run Hong Pharmaceutical Co., Ltd. romanized国药准字H202443395ml:0.5g2024/06/28Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H202442455ml:0.25g2024/06/28Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H202442465ml:0.5g2024/06/28Official source ↗
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024392510ml:1.0g2024/06/04Official source ↗
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202439245ml:0.25g2024/06/04Official source ↗
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H2024339110ml∶1g2024/03/29Official source ↗
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202433905ml∶0.5g2024/03/29Official source ↗
Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized国药准字H202470425ml︰0.5g2024/03/07Official source ↗
Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized国药准字H201840475ml︰0.25g2024/03/07Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H200544435ml:0.5g2023/12/18Official source ↗
Hubei Duo Rui Pharma Co., Ltd. romanized国药准字H2023448510ml:1.0g2023/11/14Official source ↗
Jilin Si Zhang Pharmaceutical Co., Ltd. romanized国药准字H202336615ml:0.25g2023/06/07Official source ↗
Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized国药准字H202336865ml:0.25g2023/06/07Official source ↗
Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized国药准字H202336852.5ml:0.25g2023/06/07Official source ↗
Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized国药准字H200630685ml︰0.5g2023/04/05Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H202334242.5ml:0.25g2023/04/04Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H2023342310ml:1.0g2023/04/04Official source ↗
Peng Lai Nuo Kang Pharma Co., Ltd. romanized国药准字H202331125ml:0.25g2023/01/31Official source ↗
Peng Lai Nuo Kang Pharma Co., Ltd. romanized国药准字H2023311310ml:1.0g2023/01/31Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219625ml︰0.5g2023/01/18Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219615ml︰0.25g2023/01/18Official source ↗
Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized国药准字H202239692.5ml:0.25g2022/12/30Official source ↗
Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized国药准字H202239555ml : 0.25g2022/12/30Official source ↗
Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized国药准字H202238365mL:0.25g2022/11/08Official source ↗
Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202238392.5ml:0.25g2022/11/08Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H202237645ml:0.5g2022/10/25Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H2022376510ml:1.0g2022/10/25Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566005ml:0.25g2022/08/23Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566015ml:0.5g2022/08/23Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205655ml:0.5g2022/07/22Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H2010373010ml:1.0g2022/07/22Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H2022338910ml:1.0g2022/06/16Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202233885ml:0.5g2022/06/16Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202233875ml:0.25g2022/06/16Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H202270702.5ml:0.25g2022/05/23Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H2022706910ml:1.0g2022/05/23Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized国药准字H201835075ml:0.25g2022/03/02Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized国药准字H202270245ml:0.5g2022/03/02Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230035ml:0.25g2022/02/18Official source ↗
Shanxi Pu De Pharma Co., Ltd. romanized国药准字H140208875ml:0.5g2022/01/18Official source ↗
Shanxi Pu De Pharma Co., Ltd. romanized国药准字H2022700610ml:1.0g2022/01/18Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H200935585ml:0.5g2021/04/21Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H200935575ml:0.25g2021/04/21Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219925ml:0.25g2021/04/21Official source ↗
Shanxi Pu De Pharma Co., Ltd. romanized国药准字H140208885ml:0.25g2021/01/18Official source ↗
Chengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202345595ml:0.25g2023/11/28Official source ↗

NHSA approval numbers 106

Company (original)Identifier (original)Source dateOfficial source
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H201980092ml:0.2g—Official source ↗
Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized国药准字H2005698710ml:1.0g—Official source ↗
Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized国药准字H310218565ml:0.25g—Official source ↗
Xi Nan Pharma Co., Ltd. romanized国药准字H500201275ml:0.25g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566005ml:0.25g—Official source ↗
Dan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210235542ml:0.1g—Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H2023342310ml:1.0g—Official source ↗
Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized国药准字H320220342ml:0.1g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230045ml:0.5g—Official source ↗
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H2005747610ml:1.0g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H420210432ml:0.1g—Official source ↗
Wuhan Ai Min Pharmaceutical Co., Ltd. romanized国药准字H420218242ml:0.1g—Official source ↗
Yi Chang Ren Fu Pharma Co., Ltd. romanized国药准字H200575472ml:0.25g—Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202233875ml:0.25g—Official source ↗
Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized国药准字H202270702.5ml:0.25g—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219592ml:0.1g—Official source ↗
Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized国药准字H202239692.5ml:0.25g—Official source ↗
Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202238392.5ml:0.25g—Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H200935575ml:0.25g—Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446815ml:0.5g—Official source ↗
Hebei Mei Tu Pharmaceutical Co., Ltd. romanized国药准字H130219332ml:0.1g—Official source ↗
Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized国药准字H140208862ml:0.2g—Official source ↗
Kai Feng Pharmaceutical (Group) Co., Ltd. romanized国药准字H200681205ml:0.25g—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H410252962ml:0.1g—Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H410215682ml:0.1g—Official source ↗
Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized国药准字H201840475ml:0.25g—Official source ↗
Henan Run Hong Pharmaceutical Co., Ltd. romanized国药准字H202443395ml:0.5g—Official source ↗
Jilin Si Zhang Pharmaceutical Co., Ltd. romanized国药准字H202336615ml:0.25g—Official source ↗
Heilongjiang Sheng Ge Run Pharma Co., Ltd. romanized国药准字H230221742ml:0.1g—Official source ↗
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H2010354210ml:1g—Official source ↗
Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized国药准字H202331125ml:0.25g—Official source ↗
Shandong Qidu Pharmaceutical Co., Ltd.国药准字H201634422ml:0.1g—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219932ml:0.1g—Official source ↗
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202439245ml:0.25g—Official source ↗
Zhejiang Cheng Yi Pharma Co., Ltd. romanized国药准字H330214225ml:0.25g—Official source ↗
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized国药准字H2005950510ml:1g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H2010373010ml:1.0g—Official source ↗
Zi Guang Gu Han Group Heng Yang Pharmaceutical Co., Ltd. romanized国药准字H430212725ml:0.5g—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H200544422ml:0.2g—Official source ↗
Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized国药准字H200630685ml:0.5g—Official source ↗
Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized国药准字H202238365ml:0.25g—Official source ↗
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H200535685ml:0.25g—Official source ↗
Hainan Ai Ke Pharmaceutical Co., Ltd. romanized国药准字H202634615ml:0.25g—Official source ↗
Hubei Duo Rui Pharma Co., Ltd. romanized国药准字H2023448510ml:1.0g—Official source ↗
Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized国药准字H202239555ml : 0.25g—Official source ↗
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202433905ml:0.5g—Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized国药准字H201835075ml:0.25g—Official source ↗
Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized国药准字H202336852.5ml:0.25g—Official source ↗
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202558005ml:0.25g—Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H202442465ml:0.5g—Official source ↗
Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized国药准字H202496305ml:0.25g—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H201980092ml:0.2g—Official source ↗
Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized国药准字H2005698710ml:1.0g—Official source ↗
Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized国药准字H310218565ml:0.25g—Official source ↗
Xi Nan Pharma Co., Ltd. romanized国药准字H500201275ml:0.25g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566005ml:0.25g—Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H2023342310ml:1.0g—Official source ↗
Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized国药准字H320220342ml:0.1g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230045ml:0.5g—Official source ↗
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H2005747610ml:1.0g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H420210432ml:0.1g—Official source ↗
Wuhan Ai Min Pharmaceutical Co., Ltd. romanized国药准字H420218242ml:0.1g—Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202233885ml:0.5g—Official source ↗
Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized国药准字H202270702.5ml:0.25g—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219602ml:0.2g—Official source ↗
Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized国药准字H202239692.5ml:0.25g—Official source ↗
Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202238392.5ml:0.25g—Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H200935585ml:0.5g—Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446815ml:0.5g—Official source ↗
Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized国药准字H140208862ml:0.2g—Official source ↗
Kai Feng Pharmaceutical (Group) Co., Ltd. romanized国药准字H200681205ml:0.25g—Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H410215682ml:0.1g—Official source ↗
Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized国药准字H201840475ml:0.25g—Official source ↗
Jilin Si Zhang Pharmaceutical Co., Ltd. romanized国药准字H202336615ml:0.25g—Official source ↗
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H2010354210ml:1g—Official source ↗
Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized国药准字H202331125ml:0.25g—Official source ↗
Shandong Qidu Pharmaceutical Co., Ltd.国药准字H201634422ml:0.1g—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219932ml:0.1g—Official source ↗
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202439245ml:0.25g—Official source ↗
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized国药准字H2005950510ml:1g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H2010373010ml:1.0g—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H200544422ml:0.2g—Official source ↗
Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized国药准字H200630685ml:0.5g—Official source ↗
Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized国药准字H202238365ml:0.25g—Official source ↗
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H200535685ml:0.25g—Official source ↗
Hubei Duo Rui Pharma Co., Ltd. romanized国药准字H2023448510ml:1.0g—Official source ↗
Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized国药准字H202239555ml : 0.25g—Official source ↗
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202433905ml:0.5g—Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized国药准字H201835075ml:0.25g—Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H202442465ml:0.5g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566005ml:0.25g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221445ml:0.5g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230045ml:0.5g—Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202233875ml:0.25g—Official source ↗
Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202238392.5ml:0.25g—Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H200935585ml:0.5g—Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H410215682ml:0.1g—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219932ml:0.1g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H2010373010ml:1.0g—Official source ↗
Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized国药准字H202238365ml:0.25g—Official source ↗
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H200535685ml:0.25g—Official source ↗
Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized国药准字H202239555ml : 0.25g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221445ml:0.5g—Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202233885ml:0.5g—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H202237645ml:0.5g—Official source ↗
Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized国药准字H200569865ml:0.5g—Official source ↗
Xi Nan Pharma Co., Ltd. romanized国药准字H500201152ml:0.1g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566015ml:0.5g—Official source ↗
Dan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210206445ml:0.25g—Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H202334242.5ml:0.25g—Official source ↗
Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized国药准字H320220332ml:0.2g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230052ml:0.1g—Official source ↗
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H200574752ml:0.2g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H200446015ml:0.5g—Official source ↗
Wuhan Ai Min Pharmaceutical Co., Ltd. romanized国药准字H420218255ml:0.25g—Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H2022338910ml:1.0g—Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H2022706910ml:1.0g—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219615ml:0.25g—Official source ↗
Chengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202345595ml:0.25g—Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H200935575ml:0.25g—Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446825ml:0.25g—Official source ↗
Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized国药准字H140208885ml:0.25g—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H410252962ml:0.1g—Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H202580235ml:0.25g—Official source ↗
Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized国药准字H202470425ml:0.5g—Official source ↗
Henan Run Hong Pharmaceutical Co., Ltd. romanized国药准字H2024434010ml:1.0g—Official source ↗
Heilongjiang Sheng Ge Run Pharma Co., Ltd. romanized国药准字H2005829310ml:1g—Official source ↗
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H201035415ml:0.5g—Official source ↗
Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized国药准字H2023311310ml:1.0g—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219925ml:0.25g—Official source ↗
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024392510ml:1.0g—Official source ↗
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized国药准字H200595045ml:0.5g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H199941392ml:0.2g—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H200544435ml:0.5g—Official source ↗
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H200535695ml:0.5g—Official source ↗
Hainan Ai Ke Pharmaceutical Co., Ltd. romanized国药准字H202634625ml:0.5g—Official source ↗
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H2024339110ml:1g—Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized国药准字H202270245ml:0.5g—Official source ↗
Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized国药准字H202336865ml:0.25g—Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H2024424710ml:1.0g—Official source ↗
Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized国药准字H2024963210ml:1.0g—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H202237645ml:0.5g—Official source ↗
Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized国药准字H200569865ml:0.5g—Official source ↗
Xi Nan Pharma Co., Ltd. romanized国药准字H500201152ml:0.1g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566015ml:0.5g—Official source ↗
Dan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210206445ml:0.25g—Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H202334242.5ml:0.25g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H2005985110ml:1g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230062ml:0.2g—Official source ↗
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H200574752ml:0.2g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H200446015ml:0.5g—Official source ↗
Wuhan Ai Min Pharmaceutical Co., Ltd. romanized国药准字H420218255ml:0.25g—Official source ↗
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H2022338910ml:1.0g—Official source ↗
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H2022706910ml:1.0g—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219625ml:0.5g—Official source ↗
Chengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202345595ml:0.25g—Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446825ml:0.25g—Official source ↗
Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized国药准字H140208885ml:0.25g—Official source ↗
Topfond Pharmaceutical Co., Ltd.国药准字H202580235ml:0.25g—Official source ↗
Heilongjiang Sheng Ge Run Pharma Co., Ltd. romanized国药准字H2005829310ml:1g—Official source ↗
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H201035415ml:0.5g—Official source ↗
Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized国药准字H2023311310ml:1.0g—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219925ml:0.25g—Official source ↗
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024392510ml:1.0g—Official source ↗
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized国药准字H200595045ml:0.5g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H199941392ml:0.2g—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H200544435ml:0.5g—Official source ↗
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H200535695ml:0.5g—Official source ↗
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H2024339110ml:1g—Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized国药准字H202270245ml:0.5g—Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H2024424710ml:1.0g—Official source ↗
Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized国药准字H200569865ml:0.5g—Official source ↗
Xi Nan Pharma Co., Ltd. romanized国药准字H500201152ml:0.1g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566015ml:0.5g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H2005985110ml:1g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230052ml:0.1g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H200446015ml:0.5g—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219625ml:0.5g—Official source ↗
Chengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202345595ml:0.25g—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H370219925ml:0.25g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230062ml:0.2g—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H2022376510ml:1.0g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566005ml:0.25g—Official source ↗
Dan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210235542ml:0.1g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221452ml:0.1g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230035ml:0.25g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H2005627710ml:1g—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510219615ml:0.25g—Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446832.5ml:0.25g—Official source ↗
Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized国药准字H140208875ml:0.5g—Official source ↗
Heilongjiang Sheng Ge Run Pharma Co., Ltd. romanized国药准字H230221735ml:0.25g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205655ml:0.5g—Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H202442455ml:0.25g—Official source ↗
Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized国药准字H202496315ml:0.5g—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H2022376510ml:1.0g—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H200566015ml:0.5g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221422ml:0.2g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230035ml:0.25g—Official source ↗
Xian Han Feng Pharma Co., Ltd. romanized国药准字H202446832.5ml:0.25g—Official source ↗
Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized国药准字H140208875ml:0.5g—Official source ↗
Heilongjiang Sheng Ge Run Pharma Co., Ltd. romanized国药准字H230221735ml:0.25g—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205655ml:0.5g—Official source ↗
Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized国药准字H202442455ml:0.25g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221422ml:0.2g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230035ml:0.25g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221452ml:0.1g—Official source ↗
Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized国药准字H201230035ml:0.25g—Official source ↗
Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized国药准字H320220332ml:0.2g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221435ml:0.25g—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H2005627710ml:1g—Official source ↗
Mei Xiang Biopharmaceutical (Zhuhai) Co., Ltd. romanized国药准字H2022700610ml:1.0g—Official source ↗
Jiangsu Lang Ou Pharma Co., Ltd. romanized国药准字H320221435ml:0.25g—Official source ↗
Mei Xiang Biopharmaceutical (Zhuhai) Co., Ltd. romanized国药准字H2022700610ml:1.0g—Official source ↗

Under review 11

Company (original)Identifier (original)Source dateOfficial source
Nanjing Yi Teng Drug Research Institute Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanizedCYHS26002392026/01/21Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHB26018012026/09/23Official source ↗
CISEN PHARMACEUTICAL CO., LTD.CYHS26023202026/09/17Official source ↗
CISEN PHARMACEUTICAL CO., LTD.CYHS26023192026/09/17Official source ↗
Hunan Xian Shi Pharmaceutical Co., Ltd. romanizedCYHS26003902026/02/06Official source ↗
Hunan Xian Shi Pharmaceutical Co., Ltd. romanizedCYHS26003892026/02/06Official source ↗
Chengdu Hua Yu Pharmaceutical Co., Ltd. romanizedCYHS25040822025/11/27Official source ↗
Shandong Yi Jian Pharma Co., Ltd. romanizedCYHB25503382025/10/14Official source ↗
Henan Pu Rui Pharma Co., Ltd. romanizedCYHS25027002025/07/25Official source ↗
Henan Pu Rui Pharma Co., Ltd. romanizedCYHS25026992025/07/25Official source ↗
Henan Pu Rui Pharma Co., Ltd. romanizedCYHS25026982025/07/25Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Nanjing Yi Teng Drug Research Institute Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanizedCYHS26002392026/01/21Official source ↗
CISEN PHARMACEUTICAL CO., LTD.CYHS26023202026/09/17Official source ↗
CISEN PHARMACEUTICAL CO., LTD.CYHS26023192026/09/17Official source ↗
Hunan Xian Shi Pharmaceutical Co., Ltd. romanizedCYHS26003902026/02/06Official source ↗
Hunan Xian Shi Pharmaceutical Co., Ltd. romanizedCYHS26003892026/02/06Official source ↗

API companies with A status 15

Company (original)Identifier (original)Source dateOfficial source
Sichuan Ren An Pharma Co., Ltd. romanizedY202400012822026/02/09Official source ↗
Ami lifesciences Pvt. Ltd.Y202100003152026/09/06Official source ↗
Hunan Sai Long Pharma Co., Ltd. romanizedY202100001772026/05/08Official source ↗
DAIICHI SANKYO CO.,LTD.Y20190009106—Official source ↗
Xian Li Bang Pharmaceutical Co., Ltd. romanizedY201900089312024/01/31Official source ↗
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.Y201900068682023/03/24Official source ↗
Hubei Zhong Jia He Cheng Pharmaceutical Co., Ltd. romanizedY201900063252026/04/15Official source ↗
Changzhou Yin Sheng Pharma Co., Ltd. romanizedY201900061812025/12/23Official source ↗
Kai Feng Pharmaceutical (Group) Co., Ltd. romanizedY201900044452024/09/11Official source ↗
Hua Run Shuang He Pharma Co., Ltd. romanizedY20190003756—Official source ↗
Hunan Dong Ting Pharma Co., Ltd. romanizedY201900028952025/03/04Official source ↗
Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20190002704—Official source ↗
Hainan Huluwa Pharmaceutical Group Co., Ltd.Y201900024482024/07/16Official source ↗
Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanizedY201900016772025/03/12Official source ↗
Yan Tai Wan Run Pharma Co., Ltd. romanizedY201700004472024/01/12Official 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