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Methylprednisolone Sodium Succinate for injection

Matched
Active ingredients (original)
METHYLPREDNISOLONE SODIUM SUCCINATE
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 approvalApproved before 1982
ANDA applications48
RLD applicantPHARMACIA AND UPJOHN CO

Currently marketed products: 24 · 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
A040583-001METHYLPREDNISOLONE SODIUM SUCCINATEFRESENIUS KABI USA LLCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2004/07/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040583-002METHYLPREDNISOLONE SODIUM SUCCINATEFRESENIUS KABI USA LLCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2004/07/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040612-001METHYLPREDNISOLONE SODIUM SUCCINATEFRESENIUS KABI USA LLCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL2004/08/12N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040641-002METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABORATORIESINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2007/02/21N / NDISCONTINUEDopenFDA ↗
A040641-003METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABORATORIESINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL2007/02/21N / NDISCONTINUEDopenFDA ↗
A040641-004METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABORATORIESINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL2007/02/21N / NDISCONTINUEDopenFDA ↗
A040662-001METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABORATORIESINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2007/02/21N / NDISCONTINUEDopenFDA ↗
A040664-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2005/12/20N / NDISCONTINUEDopenFDA ↗
A040665-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2005/12/20N / NDISCONTINUEDopenFDA ↗
A040709-001METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABORATORIESINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL2007/02/21N / NDISCONTINUEDopenFDA ↗
A040709-002METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABORATORIESINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL2007/02/21N / NDISCONTINUEDopenFDA ↗
A040793-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2008/11/25N / NDISCONTINUEDopenFDA ↗
A040827-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2008/11/25N / NDISCONTINUEDopenFDA ↗
A040888-001METHYLPREDNISOLONE SODIUM SUCCINATESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2011/07/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040888-002METHYLPREDNISOLONE SODIUM SUCCINATESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2011/07/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040888-003METHYLPREDNISOLONE SODIUM SUCCINATESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL2011/07/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040888-004METHYLPREDNISOLONE SODIUM SUCCINATESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL2011/07/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A040888-005METHYLPREDNISOLONE SODIUM SUCCINATESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 2GM BASE/VIAL2011/07/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A081266-001METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL1992/11/30N / NDISCONTINUEDopenFDA ↗
A081267-001METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1992/11/30N / NDISCONTINUEDopenFDA ↗
A081268-001METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1992/11/30N / NDISCONTINUEDopenFDA ↗
A085852-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A085853-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A085854-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A085855-001A-METHAPREDHOSPIRA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A086906-001METHYLPREDNISOLONE SODIUM SUCCINATEELKINS SINN DIV AH ROBINS CO INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A086906-002METHYLPREDNISOLONEELKINS SINN DIV AH ROBINS CO INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A086906-003METHYLPREDNISOLONEELKINS SINN DIV AH ROBINS CO INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A086906-004METHYLPREDNISOLONEELKINS SINN DIV AH ROBINS CO INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
A086953-001METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABORATORIES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL1982/07/22N / NDISCONTINUEDopenFDA ↗
A087030-001METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABORATORIES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL1982/07/22N / NDISCONTINUEDopenFDA ↗
A087535-001METHYLPREDNISOLONEORGANON USA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1982/06/25N / NDISCONTINUEDopenFDA ↗
A087535-002METHYLPREDNISOLONEORGANON USA INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1982/06/25N / NDISCONTINUEDopenFDA ↗
A087812-001METHYLPREDNISOLONE SODIUM SUCCINATEINTERNATIONAL MEDICATION SYSTEMS LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL1983/02/09N / NDISCONTINUEDopenFDA ↗
A087813-001METHYLPREDNISOLONE SODIUM SUCCINATEINTERNATIONAL MEDICATION SYSTEMS LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL1983/02/09N / NDISCONTINUEDopenFDA ↗
A087851-001METHYLPREDNISOLONE SODIUM SUCCINATEINTERNATIONAL MEDICATION SYSTEMS LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1983/02/09N / NDISCONTINUEDopenFDA ↗
A087852-001METHYLPREDNISOLONE SODIUM SUCCINATEINTERNATIONAL MEDICATION SYSTEMS LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1983/02/09N / NDISCONTINUEDopenFDA ↗
A088523-001METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABORATORIES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1984/07/24N / NDISCONTINUEDopenFDA ↗
A088524-001METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABORATORIES INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1984/07/24N / NDISCONTINUEDopenFDA ↗
A088676-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL1984/06/08N / NDISCONTINUEDopenFDA ↗
A088677-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL1984/06/08N / NDISCONTINUEDopenFDA ↗
A088678-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1984/06/08N / NDISCONTINUEDopenFDA ↗
A088679-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1984/06/08N / NDISCONTINUEDopenFDA ↗
A089143-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL1986/03/28N / NDISCONTINUEDopenFDA ↗
A089144-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL1986/03/28N / NDISCONTINUEDopenFDA ↗
A089173-001A-METHAPREDHOSPIRA WORLDWIDE, INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1987/08/18N / NDISCONTINUEDopenFDA ↗
A089174-001A-METHAPREDHOSPIRA WORLDWIDE, INCINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1987/08/18N / NDISCONTINUEDopenFDA ↗
A089186-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1986/03/28N / NDISCONTINUEDopenFDA ↗
A089187-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1986/03/28N / NDISCONTINUEDopenFDA ↗
A089188-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1986/03/28N / NDISCONTINUEDopenFDA ↗
A089189-001METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1986/03/28N / NDISCONTINUEDopenFDA ↗
A089573-001A-METHAPREDABBOTT LABORATORIES HOSP PRODUCTS DIVINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL1991/02/22N / NDISCONTINUEDopenFDA ↗
A089574-001A-METHAPREDABBOTT LABORATORIES HOSP PRODUCTS DIVINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL1991/02/22N / NDISCONTINUEDopenFDA ↗
A089575-001A-METHAPREDABBOTT LABORATORIES HOSP PRODUCTS DIVINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL1991/02/22N / NDISCONTINUEDopenFDA ↗
A089576-001A-METHAPREDABBOTT LABORATORIES HOSP PRODUCTS DIVINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL1991/02/22N / NDISCONTINUEDopenFDA ↗
A202691-001METHYLPREDNISOLONE SODIUM SUCCINATEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL2016/02/16N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A202691-002METHYLPREDNISOLONE SODIUM SUCCINATEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL2016/02/16N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A203125-001METHYLPREDNISOLONE SODIUM SUCCINATEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2022/09/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A203125-002METHYLPREDNISOLONE SODIUM SUCCINATEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2022/09/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207549-001METHYLPREDNISOLONE SODIUM SUCCINATEAMNEAL EU LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2016/11/09N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207549-002METHYLPREDNISOLONE SODIUM SUCCINATEAMNEAL EU LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2016/11/09N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207667-001METHYLPREDNISOLONE SODIUM SUCCINATEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2015/12/15N / NDISCONTINUEDopenFDA ↗
A207667-002METHYLPREDNISOLONE SODIUM SUCCINATEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2015/12/15N / NDISCONTINUEDopenFDA ↗
A207667-003METHYLPREDNISOLONE SODIUM SUCCINATEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL2015/12/15N / NDISCONTINUEDopenFDA ↗
A207667-004METHYLPREDNISOLONE SODIUM SUCCINATEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 2GM BASE/VIAL2015/12/15N / NDISCONTINUEDopenFDA ↗
A212396-001METHYLPREDNISOLONE SODIUM SUCCINATETIANJIN KINGYORK PHARMACEUTICALS CO LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIAL2021/04/20N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212396-002METHYLPREDNISOLONE SODIUM SUCCINATETIANJIN KINGYORK PHARMACEUTICALS CO LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIAL2021/04/20N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212396-003METHYLPREDNISOLONE SODIUM SUCCINATETIANJIN KINGYORK PHARMACEUTICALS CO LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL2021/04/20N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212396-004METHYLPREDNISOLONE SODIUM SUCCINATETIANJIN KINGYORK PHARMACEUTICALS CO LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL2021/04/20N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212396-005METHYLPREDNISOLONE SODIUM SUCCINATETIANJIN KINGYORK PHARMACEUTICALS CO LTDINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 2GM BASE/VIAL2021/04/20N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N011856-003SOLU-MEDROLPHARMACIA AND UPJOHN COINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 40MG BASE/VIALApproved before 1982Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N011856-004SOLU-MEDROLPHARMACIA AND UPJOHN COINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 125MG BASE/VIALApproved before 1982Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N011856-005SOLU-MEDROLPHARMACIA AND UPJOHN COINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 500MG BASE/VIALApproved before 1982Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N011856-006SOLU-MEDROLPHARMACIA AND UPJOHN COINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 1GM BASE/VIALApproved before 1982Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N011856-007SOLU-MEDROLPHARMACIA AND UPJOHN COINJECTABLEINJECTIONMETHYLPREDNISOLONE SODIUM SUCCINATE: EQ 2GM BASE/VIAL1985/02/27Y / 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 11

Company (original)Identifier (original)Source dateOfficial source
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H20173357See source2025/12/11Official source ↗
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20247165See source2024/07/15Official source ↗
Han Hui Pharmaceutical Co., Ltd. romanized国药准字H2023717240mg2023/12/11Official source ↗
Han Hui Pharmaceutical Co., Ltd. romanized国药准字H20237173500mg2023/12/11Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20237074See source2023/07/05Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H20233369See source2023/03/24Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H20233368See source2023/03/24Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183041See source2023/02/23Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20203329See source2022/01/30Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20143136See source2021/10/11Official source ↗
Tianjin Jin Yao Pharma Co., Ltd. romanized国药准字H20103047See source2021/05/31Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20153195See source2021/05/25Official source ↗
Tianjin Jin Yao Pharma Co., Ltd. romanized国药准字H20217036See source2021/05/10Official source ↗
Tianjin Jin Yao Pharma Co., Ltd. romanized国药准字H20123319See source2021/05/10Official source ↗
Tianjin Jin Yao Pharma Co., Ltd. romanized国药准字H20217037See source2021/05/10Official source ↗
Tianjin Jin Yao Pharma Co., Ltd. romanized国药准字H20217038See source2021/05/10Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20040845See source2021/04/16Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20010098See source2021/04/16Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20030727See source2021/04/16Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20040844See source2021/04/16Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20070007See source2021/04/16Official source ↗
Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20133233See source2021/03/26Official source ↗
Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20133234See source2021/03/26Official source ↗
PFIZER SAH2017019740mg1988/09/01Official source ↗
PFIZER SAH20170199500mg1988/09/01Official source ↗

NHSA approval numbers 34

Company (original)Identifier (original)Source dateOfficial source
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20247165See source—Official source ↗
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20103047See source—Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20153195See source—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20203329See source—Official source ↗
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H20173357See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20040845See source—Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H20233368See source—Official source ↗
Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20133233See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183040See source—Official source ↗
Han Hui Pharmaceutical Co., Ltd. romanized国药准字H2023717240mg—Official source ↗
PFIZER SAH20170199500mg—Official source ↗
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20103047See source—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20203329See source—Official source ↗
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H20173357See source—Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H20233368See source—Official source ↗
Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20133233See source—Official source ↗
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20103047See source—Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20143136See source—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20203238See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20040844See source—Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H20233369See source—Official source ↗
Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20133234See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183039See source—Official source ↗
Han Hui Pharmaceutical Co., Ltd. romanized国药准字H20237173500mg—Official source ↗
PFIZER SAH2017019740mg—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanizedHC20150041250mg—Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20143136See source—Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20203238See source—Official source ↗
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H20233369See source—Official source ↗
Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20133234See source—Official source ↗
PFIZER SA国药准字HJ2017019740mg—Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20143136See source—Official source ↗
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20153195See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20030727See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183041See source—Official source ↗
PFIZER NV/SA国药准字HJ20170199500mg—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanizedHC20150042500mg—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20030727See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20030727See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183041See source—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanizedHC2016003940mg—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20040844See source—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanizedHC2016003940mg—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanized国药准字HC2016003940mg—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanized国药准字HC2016003940mg—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20040845See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183040See source—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanized国药准字HC20150040See source—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanized国药准字HC20150040See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20010098See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20183039See source—Official source ↗
Nang Kuang Pharmaceutical Co., Ltd国药准字HC20150041See source—Official source ↗
Nang Kuang Pharmaceutical Co., Ltd国药准字HC20150041See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20070007See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20237074See source—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanized国药准字HC20150042See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20070007See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20237074See source—Official source ↗
Nan Guang Chemical Pharmaceutical Co., Ltd. romanized国药准字HC20150042See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20070007See source—Official source ↗
Tianjin Jin Yao Pharma Co., Ltd. romanized国药准字H20123319See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20070007See source—Official source ↗
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H20070007See source—Official source ↗

Under review 12

Company (original)Identifier (original)Source dateOfficial source
Nanjing Huang Long Bio Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS26014372026/06/17Official source ↗
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS26018222026/07/29Official source ↗
Nang Kuang Pharmaceutical Co. Ltd; Hainan zhenyuanPharmaceutical Co. Ltd.JYHZ26001632026/07/07Official source ↗
Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanizedCYHS26014732026/06/23Official source ↗
Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanizedCYHS26014722026/06/23Official source ↗
Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedCYHS26004472026/02/11Official source ↗
Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS25036412025/10/14Official source ↗
Chongqing Lai Mei Pharma Co., Ltd. romanizedCYHB25015692025/08/08Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS25024462025/07/09Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS25024452025/07/09Official source ↗
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS25018162025/05/20Official source ↗
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS25018152025/05/20Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Nanjing Huang Long Bio Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS26014372026/06/17Official source ↗
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS26018222026/07/29Official source ↗
Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanizedCYHS26014732026/06/23Official source ↗
Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanizedCYHS26014722026/06/23Official source ↗
Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedCYHS26004472026/02/11Official source ↗

API companies with A status 1

Company (original)Identifier (original)Source dateOfficial source
Henan Li Hua Pharmaceutical Co., Ltd. romanizedY201700016692024/09/11Official 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