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Colistimethate Sodium for Injection

Matched
Active ingredients (original)
COLISTIMETHATE SODIUM
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 applications6
RLD applicantPH HEALTH LTD

Currently marketed products: 4 · 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
A064216-001COLISTIMETHATE SODIUMPHARMOBEDIENT CONSULTING LLCINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIAL1999/02/26N / NDISCONTINUEDopenFDA ↗
A065177-001COLISTIMETHATE SODIUMNEXUS PHARMACEUTICALS LLCINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIAL2004/03/19N / NDISCONTINUEDopenFDA ↗
A065364-001COLISTIMETHATE SODIUMFRESENIUS KABI USA LLCINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIAL2008/04/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A201365-001COLISTIMETHATE SODIUMSAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIAL2014/02/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A202359-001COLISTIMETHATE SODIUMAVET LIFESCIENCES LTDINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIAL2012/09/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205356-001COLISTIMETHATE SODIUMXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIAL2015/05/29N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N050108-002COLY-MYCIN MPH HEALTH LTDINJECTABLEINJECTIONCOLISTIMETHATE SODIUM: EQ 150MG BASE/VIALApproved before 1982Y / 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 2

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized国药准字H20213795See source2021/10/19Official source ↗
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213773See source2021/10/11Official source ↗

NHSA approval numbers 2

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized国药准字H20213795See source—Official source ↗
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213773See source—Official source ↗
Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized国药准字H20213795See source—Official source ↗
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213773See source—Official source ↗

Under review 2

Company (original)Identifier (original)Source dateOfficial source
NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Yangtze River Pharmaceutical Group Co., LtdCYHS26025512026/10/16Official source ↗
Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS26017622026/07/22Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Yangtze River Pharmaceutical Group Co., LtdCYHS26025512026/10/16Official source ↗
Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS26017622026/07/22Official source ↗

API companies with A status 5

Company (original)Identifier (original)Source dateOfficial source
Sichuan Nuo Yi Sheng Pharma Co., Ltd. romanizedY202400012132026/05/21Official source ↗
Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanizedY202400003142025/11/03Official source ↗
Li Zhu Group Fuzhou Fu Xing Pharmaceuticals Co., Ltd. romanizedY202200000692024/03/25Official source ↗
Xellia Pharmaceuticals ApSY201800012972023/08/01Official source ↗
Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY201800017242026/05/22Official 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