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Azithromycin For Injection

Matched
Active ingredients (original)
AZITHROMYCIN
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 approval1997/01/30
ANDA applications10
RLD applicantPFIZER INC

Currently marketed products: 5 · 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
A065179-001AZITHROMYCINFRESENIUS KABI USA LLCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2005/12/13N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065265-001AZITHROMYCINHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2007/01/18N / NDISCONTINUEDopenFDA ↗
A065500-001AZITHROMYCINHOSPIRA INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2009/06/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065501-001AZITHROMYCINGLAND PHARMA LTDINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2009/11/09N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065506-001AZITHROMYCINPHARMOBEDIENT CONSULTING LLCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2009/03/24N / NDISCONTINUEDopenFDA ↗
A065511-001AZITHROMYCINHOSPIRA INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2009/06/26N / NDISCONTINUEDopenFDA ↗
A090923-001AZITHROMYCINSUN PHARMACEUTICAL INDUSTRIES LTDINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2013/04/02N / NDISCONTINUEDopenFDA ↗
A203294-001AZITHROMYCINEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2015/06/19N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A203412-001AZITHROMYCINHAINAN POLY PHARM CO LTDINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2018/10/09N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204732-001AZITHROMYCINRISING PHARMA HOLDING INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2017/01/26N / NDISCONTINUEDopenFDA ↗
N050733-001ZITHROMAXPFIZER INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL1997/01/30Y / NDISCONTINUEDopenFDA ↗
N050809-001AZITHROMYCINTEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 500MG BASE/VIAL2006/12/19N / NDISCONTINUEDopenFDA ↗
N050809-002AZITHROMYCINTEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONAZITHROMYCIN: EQ 2.5GM BASE/VIAL2006/12/19N / NDISCONTINUEDopenFDA ↗

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 34

Company (original)Identifier (original)Source dateOfficial source
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066472See source2026/07/02Official source ↗
Nanjing Healthnice Pharmaceutical Technology Co., Ltd国药准字H20264095See source2026/04/21Official source ↗
Changchun Hai Yue Pharma Co., Ltd. romanized国药准字H20213102See source2025/08/27Official source ↗
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20254211See source2025/05/20Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20244688See source2024/08/20Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H20030164See source2024/05/08Official source ↗
Dong Yao Group Shenyang Shi De Pharma Co., Ltd. romanized国药准字H20243582See source2024/04/24Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20237135See source2023/10/27Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20237127See source2023/10/24Official source ↗
Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized国药准字H20234287See source2023/10/12Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20056283See source2023/08/21Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066566See source2023/08/11Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20067807See source2023/03/21Official source ↗
Hubei Ke Yi Pharma Co., Ltd. romanized国药准字H20066572See source2023/02/20Official source ↗
Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized国药准字H20040447See source2023/02/15Official source ↗
Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized国药准字H20223790See source2022/11/01Official source ↗
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20223740See source2022/10/11Official source ↗
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20073807See source2022/10/08Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094017See source2022/07/22Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063286See source2022/03/28Official source ↗
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20227038See source2022/03/21Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20063421See source2021/12/24Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064851See source2021/12/08Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H20044550See source2021/11/23Official source ↗
Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H20064932See source2021/11/19Official source ↗
Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized国药准字H20217110See source2021/11/11Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20213559See source2021/06/29Official source ↗
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H20213445See source2021/06/01Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20020254See source2021/05/24Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067075See source2021/03/22Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H20030269See source2021/02/07Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050099See source2021/01/26Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20173261See source2018/05/15Official source ↗
Pfizer Inc.H20130830;H20140685;H201308310.5g2004/10/09Official source ↗

NHSA approval numbers 125

Company (original)Identifier (original)Source dateOfficial source
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H200664390.125g—Official source ↗
Shenzhen Hai Wang Pharma Co., Ltd. romanized国药准字H20064349See source—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20030249See source—Official source ↗
Dong Yao Group Shenyang Shi De Pharma Co., Ltd. romanized国药准字H20243582See source—Official source ↗
Shenyang Yao Da Lei Yun Shang Pharma Co., Ltd. romanized国药准字H20066411See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990384See source—Official source ↗
Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized国药准字H20065029See source—Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20050311See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20000328See source—Official source ↗
Hubei He Pu Pharma Co., Ltd. romanized国药准字H20064561See source—Official source ↗
Hubei Ke Yi Pharma Co., Ltd. romanized国药准字H200665710.25g—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H200445600.1g—Official source ↗
Hubei Wu Shi Pharma Co., Ltd. romanized国药准字H20066929See source—Official source ↗
Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized国药准字H20163218See source—Official source ↗
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized国药准字H200936650.25g—Official source ↗
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H20213445See source—Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066168See source—Official source ↗
Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized国药准字H20234287See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H20010118See source—Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20067808See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20237127See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20066141See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050098See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H200681270.125g—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20020530See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065172See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20244688See source—Official source ↗
Changchun Hai Yue Pharma Co., Ltd. romanized国药准字H20213102See source—Official source ↗
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20223740See source—Official source ↗
Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H20065830See source—Official source ↗
Hangzhou Guo Guang Pharma Co., Ltd. romanized国药准字H20073622See source—Official source ↗
Zhejiang Bei De Pharma Co., Ltd. romanized国药准字H200656900.25g—Official source ↗
Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized国药准字H20040447See source—Official source ↗
Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized国药准字H20094119See source—Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063285See source—Official source ↗
Zhejiang Zuo Li Pharma Co., Ltd. romanized国药准字H200741760.25g—Official source ↗
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20066937See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20063420See source—Official source ↗
Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H20064932See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20066155See source—Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H201732610.5g—Official source ↗
Hainan Shuang Cheng Pharma Co., Ltd. romanized国药准字H20074128See source—Official source ↗
Kang Zhi Pharma Co., Ltd. romanized国药准字H20067868See source—Official source ↗
Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized国药准字H20223790See source—Official source ↗
Pfizer Inc.国药准字HJ20130830See source—Official source ↗
Nanjing Healthnice Pharmaceutical Technology Co., Ltd国药准字H20264095See source—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H200664390.125g—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20030249See source—Official source ↗
Dong Yao Group Shenyang Shi De Pharma Co., Ltd. romanized国药准字H20243582See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990384See source—Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20050311See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20000328See source—Official source ↗
Hubei He Pu Pharma Co., Ltd. romanized国药准字H20064561See source—Official source ↗
Hubei Ke Yi Pharma Co., Ltd. romanized国药准字H200665710.25g—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H200445600.1g—Official source ↗
Hubei Wu Shi Pharma Co., Ltd. romanized国药准字H20066929See source—Official source ↗
Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized国药准字H20163218See source—Official source ↗
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized国药准字H200936650.25g—Official source ↗
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H20213445See source—Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066168See source—Official source ↗
Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized国药准字H20234287See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20066141See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050098See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H200681270.125g—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20020530See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065172See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20244688See source—Official source ↗
Changchun Hai Yue Pharma Co., Ltd. romanized国药准字H20213102See source—Official source ↗
Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized国药准字H20073678See source—Official source ↗
Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized国药准字H20223740See source—Official source ↗
Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H20065830See source—Official source ↗
Zhejiang Bei De Pharma Co., Ltd. romanized国药准字H200656900.25g—Official source ↗
Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized国药准字H20040447See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20063420See source—Official source ↗
Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H20064932See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000082See source—Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H201732610.5g—Official source ↗
Hainan Shuang Cheng Pharma Co., Ltd. romanized国药准字H20074128See source—Official source ↗
Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized国药准字H20093666See source—Official source ↗
Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized国药准字H20223790See source—Official source ↗
Pfizer Inc.国药准字HJ20130830See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990384See source—Official source ↗
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20050311See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20000328See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20066141See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050098See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H200681270.125g—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065172See source—Official source ↗
Changchun Hai Yue Pharma Co., Ltd. romanized国药准字H20213102See source—Official source ↗
Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized国药准字H20073678See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000082See source—Official source ↗
Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized国药准字H20093666See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990384See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990384See source—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H200664400.25g—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20030248See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990385See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20000329See source—Official source ↗
Yangtze River Pharmaceutical Group Co., Ltd国药准字H20213377See source—Official source ↗
Hubei Ke Yi Pharma Co., Ltd. romanized国药准字H20066572See source—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H199901360.25g—Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066565See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H20020269See source—Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20067807See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20066581See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050099See source—Official source ↗
Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized国药准字H200654820.5g—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20041623See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065174See source—Official source ↗
Hangzhou Guo Guang Pharma Co., Ltd. romanized国药准字H20073623See source—Official source ↗
Zhejiang Bei De Pharma Co., Ltd. romanized国药准字H20073769See source—Official source ↗
Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized国药准字H20094120See source—Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063284See source—Official source ↗
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20227038See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20063421See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067074See source—Official source ↗
Kang Zhi Pharma Co., Ltd. romanized国药准字H20067869See source—Official source ↗
Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized国药准字H20093667See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093636See source—Official source ↗
Nanjing Healthnice Pharmaceutical Technology Co., Ltd国药准字H20264095See source—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H200664400.25g—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20030248See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H19990385See source—Official source ↗
Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized国药准字H20217110See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20000329See source—Official source ↗
Yangtze River Pharmaceutical Group Co., Ltd国药准字H20213377See source—Official source ↗
Hubei Ke Yi Pharma Co., Ltd. romanized国药准字H20066572See source—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H199901360.25g—Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066565See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20066581See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050099See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20041623See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065174See source—Official source ↗
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20227038See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000083See source—Official source ↗
Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized国药准字H20093667See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093636See source—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20030248See source—Official source ↗
Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized国药准字H20217110See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20000329See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20066581See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20050099See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20041623See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000083See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093636See source—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20030248See source—Official source ↗
Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized国药准字H20217110See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093636See source—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H200664410.5g—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20056283See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H20030164See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20213559See source—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H20000358See source—Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066566See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H20000377See source—Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20067807See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20020530See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065173See source—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20237135See source—Official source ↗
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20073807See source—Official source ↗
Hangzhou Guo Guang Pharma Co., Ltd. romanized国药准字H20073624See source—Official source ↗
Zhejiang Bei De Pharma Co., Ltd. romanized国药准字H20073770See source—Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063286See source—Official source ↗
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20066937See source—Official source ↗
Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H20064932See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067075See source—Official source ↗
Kang Zhi Pharma Co., Ltd. romanized国药准字H20067870See source—Official source ↗
Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized国药准字H20093666See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093637See source—Official source ↗
Guangdong Sunho Pharmaceutical Co., Ltd.国药准字H200664410.5g—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20056283See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H20030164See source—Official source ↗
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H20213559See source—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H20000358See source—Official source ↗
E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H20066566See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H20000377See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20020530See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065173See source—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20237135See source—Official source ↗
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20073807See source—Official source ↗
Zhejiang Bei De Pharma Co., Ltd. romanized国药准字H20073770See source—Official source ↗
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20066937See source—Official source ↗
Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H20064932See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20020254See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067075See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093637See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H20030164See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20020530See source—Official source ↗
Kai Feng Kang Nuo Pharma Co., Ltd. romanized国药准字H20065173See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20020254See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093637See source—Official source ↗
Jiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H20030164See source—Official source ↗
Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized国药准字H20020530See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20020254See source—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H20093637See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20020254See source—Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H20056283See source—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H20044550See source—Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20067808See source—Official source ↗
Hangzhou Ao Ya Bio Technology Co., Ltd. romanized国药准字H19990389See source—Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063284See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20063421See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000082See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067073See source—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H20044550See source—Official source ↗
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized国药准字H200650830.25g—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000082See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067073See source—Official source ↗
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized国药准字H200650830.25g—Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanized国药准字H20044550See source—Official source ↗
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized国药准字H200650820.125g—Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063286See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20073092See source—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000083See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20066155See source—Official source ↗
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20254211See source—Official source ↗
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized国药准字H200650820.125g—Official source ↗
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20000083See source—Official source ↗
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20254211See source—Official source ↗
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized国药准字H200650840.5g—Official source ↗
Zhejiang Ya Tai Pharma Co., Ltd. romanized国药准字H20063285See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20067074See source—Official source ↗
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized国药准字H200650840.5g—Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064771See source—Official source ↗
Sichuan Bai Li Pharma Co., Ltd. romanized国药准字H20113073See source—Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064771See source—Official source ↗
Sichuan Bai Li Pharma Co., Ltd. romanized国药准字H20113073See source—Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064850See source—Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064850See source—Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064851See source—Official source ↗
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H20064851See source—Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094018See source—Official source ↗
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H20000197See source—Official source ↗
Xian Di Sai Bio Pharma Co., Ltd. romanized国药准字H200650570.25g—Official source ↗
Shandong Luo Xin Pharma Group Co., Ltd. romanized国药准字H20065405See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066473See source—Official source ↗
Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized国药准字H20030122See source—Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H20020339See source—Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094018See source—Official source ↗
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H20000197See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066776See source—Official source ↗
Shandong Luo Xin Pharma Group Co., Ltd. romanized国药准字H20065405See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066473See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H200101890.25g—Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H20020339See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066776See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066473See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066776See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066473See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066776See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066473See source—Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094019See source—Official source ↗
Xian Di Sai Bio Pharma Co., Ltd. romanized国药准字H200650580.50g—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066777See source—Official source ↗
Shandong Luo Xin Pharma Group Co., Ltd. romanized国药准字H20065406See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066472See source—Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H20020338See source—Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094019See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066777See source—Official source ↗
Shandong Luo Xin Pharma Group Co., Ltd. romanized国药准字H20065406See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066472See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H20030269See source—Official source ↗
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H20020338See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066777See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066472See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066777See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066472See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20066472See source—Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094017See source—Official source ↗
Shandong Luo Xin Pharma Group Co., Ltd. romanized国药准字H20065407See source—Official source ↗
Yue Kang Pharma Group Co., Ltd. romanized国药准字H20094017See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066778See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H20030108125mg—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066778See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066778See source—Official source ↗
CISEN PHARMACEUTICAL CO., LTD.国药准字H20066778See source—Official source ↗
Shandong Luo Xin Pharma Group Co., Ltd. romanized国药准字H20065407See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H20030269See source—Official source ↗

Under review 11

Company (original)Identifier (original)Source dateOfficial source
Xian Li Jun Pharmaceutical Co., Ltd. romanizedCYHB26502062026/10/19Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanizedCYHB26502052026/10/19Official source ↗
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanizedCYHB26017322026/09/15Official source ↗
CISEN PHARMACEUTICAL CO., LTD.CYHB26501652026/07/23Official source ↗
Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanizedCYHS26015312026/06/29Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanizedCYHB26010512026/06/04Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanizedCYHB26010502026/06/04Official source ↗
Hubei Qian Long Pharma Co., Ltd. romanizedCYHB26002882026/02/10Official source ↗
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS26002182026/01/20Official source ↗
YaoPharma Co., Ltd.CYHS25037692025/10/23Official source ↗
Hubei Wu Shi Pharma Co., Ltd. romanizedCYHB26502102026/10/26Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanizedCYHS26015312026/06/29Official source ↗
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS26002182026/01/20Official source ↗

API companies with A status 34

Company (original)Identifier (original)Source dateOfficial source
Alembic Pharmaceuticals LimitedY202400008872026/09/03Official source ↗
Ningxia Tai Yi Xin Bio Technology Co., Ltd. romanizedY202100003682026/03/02Official source ↗
Pfizer Asia Manufacturing Pte LtdY202000010872024/09/10Official source ↗
Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY201800017932023/10/17Official source ↗
TAPI Croatia Industries Ltd.Y201900099592025/10/30Official source ↗
Zhejiang Guo Bang Pharma Co., Ltd. romanizedY201900098982024/07/03Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.Y201900095552024/07/09Official source ↗
Pfizer Inc.Y201900091412024/11/12Official source ↗
Jiangsu Wei Qi Da Pharma Co., Ltd. romanizedY201900088742026/08/06Official source ↗
Huang Shi Shi Xing Pharma Co., Ltd. romanizedY201900088502026/02/07Official source ↗
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedY201900076002024/06/12Official source ↗
Kai Feng Pharmaceutical (Group) Co., Ltd. romanizedY201900065362025/07/23Official source ↗
Topfond Pharmaceutical Co., Ltd.Y201900063172024/11/01Official source ↗
Ningxia Qi Yuan Pharma Co., Ltd. romanizedY201900061732026/03/19Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanizedY201900056682026/01/07Official source ↗
Beijing Tai Yang Pharma Co., Ltd. romanizedY20190005484—Official source ↗
Yi Chang Dong Yang Guang Sheng Hua Pharmaceutical Co., Ltd. romanizedY201900053392026/02/13Official source ↗
Hebei Dong Feng Pharma Co., Ltd. romanizedY201900049762025/02/09Official source ↗
Zhejiang Bei De Pharma Co., Ltd. romanizedY201900048142025/03/04Official source ↗
Tianjin Bio Chemical Pharmaceutical Co., Ltd. romanizedY201900043932025/08/16Official source ↗
Tai Shan Shi Chemical Pharmaceutical Co., Ltd. romanizedY20190004081—Official source ↗
Hua Bei Pharmaceutical Hebei Hua Min Pharma Co., Ltd. romanizedY201900038422025/06/07Official source ↗
He Ze Shi Fang Ming Pharmaceutical Co., Ltd. romanizedY20190003689—Official source ↗
Zhejiang Nai Si Kang Pharma Co., Ltd. romanizedY201900035852025/07/05Official source ↗
Zhejiang Ao Tuo Kang Pharmaceutical Group Co., Ltd. romanizedY20190003518—Official source ↗
Zhejiang Yong Ning Pharma Co., Ltd. romanizedY201900034272024/12/10Official source ↗
Nanjing Zhang Ao Pharmaceutical Co., Ltd. romanizedY20190002838—Official source ↗
Zhejiang Jian Feng Pharma Co., Ltd. romanizedY201900025792024/11/20Official source ↗
De Zhou De Yao Pharmaceutical Co., Ltd. romanizedY201900023002025/02/07Official source ↗
Qilu Pharmaceutical Co., Ltd.Y20190001577—Official source ↗
Shao Xing Xing Ya Pharma Co., Ltd. romanizedY20190001524—Official source ↗
Sichuan Jiang Chuan Pharmaceutical Co., Ltd. romanizedY20190001366—Official source ↗
Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanizedY201900009222023/08/14Official source ↗
Hebei Guo Long Pharmaceutical Co., Ltd. romanizedY201700001822024/10/24Official 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-088. Chinese Pharmacopoeia general chapter 0102

Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗

Name and dosage-form matching sources