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Vancomycin Hydrochloride for Injection

Matched
Active ingredients (original)
VANCOMYCIN HYDROCHLORIDE
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 applications44
RLD applicant—

Currently marketed products: 49 · 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
A060180-001VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved before 1982N / NDISCONTINUEDopenFDA ↗
A060180-002VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1986/03/21N / NDISCONTINUEDopenFDA ↗
A062476-001VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1984/03/15N / NDISCONTINUEDopenFDA ↗
A062476-002VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1986/03/21N / NDISCONTINUEDopenFDA ↗
A062663-001VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1987/03/17N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062663-002VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1987/07/31N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062663-003VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL1988/06/03N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062663-004VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL1997/11/28N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062663-005VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL2016/08/17N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A062682-001VANCOLEDHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1986/07/22N / NDISCONTINUEDopenFDA ↗
A062682-002VANCOLEDHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1988/03/30N / NDISCONTINUEDopenFDA ↗
A062682-003VANCOLEDHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1988/05/11N / NDISCONTINUEDopenFDA ↗
A062682-004VANCOLEDHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1988/05/11N / NDISCONTINUEDopenFDA ↗
A062682-005VANCOLEDHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1988/05/11N / NDISCONTINUEDopenFDA ↗
A062716-001VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1987/03/13N / NDISCONTINUEDopenFDA ↗
A062716-002VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1987/03/13N / NDISCONTINUEDopenFDA ↗
A062812-001VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1987/11/17N / NDISCONTINUEDopenFDA ↗
A062812-002VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1987/11/17N / NDISCONTINUEDopenFDA ↗
A062812-003VANCOCIN HYDROCHLORIDESTERISCIENCE PTE LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1987/11/17N / NDISCONTINUEDopenFDA ↗
A062879-001VANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1988/08/02N / NDISCONTINUEDopenFDA ↗
A062879-002VANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1988/08/02N / NDISCONTINUEDopenFDA ↗
A062911-001VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1988/08/04N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062912-001VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1988/08/04N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062912-002VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL2009/01/07N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A062912-003VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1.5GM BASE/VIAL2020/07/10N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062931-001VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1992/10/29N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062933-001VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1992/10/29N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A062933-002VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL2009/05/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A062956-001VANCORPHARMACIA AND UPJOHN COINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL1988/08/01N / NDISCONTINUEDopenFDA ↗
A062956-002VANCORPHARMACIA AND UPJOHN COINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL1988/08/01N / NDISCONTINUEDopenFDA ↗
A063076-001VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL1990/12/21N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A063076-002VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2020/09/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065397-001VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2008/12/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065397-002VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2008/12/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065401-001VANCOMYCIN HYDROCHLORIDEEUROFARMA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2008/06/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065401-002VANCOMYCIN HYDROCHLORIDEEUROFARMA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2008/06/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065432-001VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2008/12/30N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A065455-001VANCOMYCIN HYDROCHLORIDEHOSPIRA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2009/04/29N / NDISCONTINUEDopenFDA ↗
A090250-001VANCOMYCIN HYDROCHLORIDEPLANO PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2010/04/27N / NDISCONTINUEDopenFDA ↗
A090250-002VANCOMYCIN HYDROCHLORIDEPLANO PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2010/04/27N / NDISCONTINUEDopenFDA ↗
A091377-001VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2015/09/09N / NDISCONTINUEDopenFDA ↗
A091377-002VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2015/09/09N / NDISCONTINUEDopenFDA ↗
A091469-001VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2011/07/01N / NDISCONTINUEDopenFDA ↗
A091554-001VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2011/09/19N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A200837-001VANCOMYCIN HYDROCHLORIDESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2012/08/10N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A200837-002VANCOMYCIN HYDROCHLORIDESAGENT PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2014/09/02N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A201048-001VANCOMYCIN HYDROCHLORIDEPLANO PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2012/08/10N / NDISCONTINUEDopenFDA ↗
A201048-002VANCOMYCIN HYDROCHLORIDEPLANO PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2012/08/10N / NDISCONTINUEDopenFDA ↗
A201250-001VANCOMYCIN HYDROCHLORIDETEVA PHARMACEUTICALS USAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2015/12/23N / NDISCONTINUEDopenFDA ↗
A201250-002VANCOMYCIN HYDROCHLORIDETEVA PHARMACEUTICALS USAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2015/12/23N / NDISCONTINUEDopenFDA ↗
A201251-001VANCOMYCIN HYDROCHLORIDETEVA PHARMACEUTICALS USAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2015/12/23N / NDISCONTINUEDopenFDA ↗
A201251-002VANCOMYCIN HYDROCHLORIDETEVA PHARMACEUTICALS USAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2015/12/23N / NDISCONTINUEDopenFDA ↗
A202274-001VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2013/10/31N / NDISCONTINUEDopenFDA ↗
A202275-001VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2013/10/31N / NDISCONTINUEDopenFDA ↗
A202275-002VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2013/10/31N / NDISCONTINUEDopenFDA ↗
A202464-001VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2013/10/09N / NDISCONTINUEDopenFDA ↗
A203300-001VANCOMYCIN HYDROCHLORIDEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2020/08/11N / NDISCONTINUEDopenFDA ↗
A203300-002VANCOMYCIN HYDROCHLORIDEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2020/08/11N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204107-001VANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2015/12/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204107-002VANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2015/12/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204125-001VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2015/12/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204125-002VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2015/12/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204360-001VANCOMYCIN HYDROCHLORIDEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2018/10/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204360-002VANCOMYCIN HYDROCHLORIDEHIKMA FARMACEUTICA PORTUGAL SAINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2018/10/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205694-001VANCOMYCIN HYDROCHLORIDEGLAND PHARMA LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2016/01/21N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205694-002VANCOMYCIN HYDROCHLORIDEGLAND PHARMA LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2016/01/21N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205694-003VANCOMYCIN HYDROCHLORIDEGLAND PHARMA LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2023/06/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205694-004VANCOMYCIN HYDROCHLORIDEGLAND PHARMA LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2023/06/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205779-001VANCOMYCIN HYDROCHLORIDEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2016/03/29N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205779-002VANCOMYCIN HYDROCHLORIDEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2016/03/29N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205780-001VANCOMYCIN HYDROCHLORIDEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2016/03/31N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205780-002VANCOMYCIN HYDROCHLORIDEEUGIA PHARMA SPECIALITIES LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2016/03/31N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A206243-001VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2015/12/23N / NDISCONTINUEDopenFDA ↗
A206243-002VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2015/12/23N / NDISCONTINUEDopenFDA ↗
A206616-001VANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALSINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL2018/10/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212332-001VANCOMYCIN HYDROCHLORIDEHAINAN POLY PHARM CO LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2019/06/12N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212332-002VANCOMYCIN HYDROCHLORIDEHAINAN POLY PHARM CO LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2019/06/12N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A213059-001VANCOMYCIN HYDROCHLORIDEKNACK PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2022/02/15N / NDISCONTINUEDopenFDA ↗
A213059-002VANCOMYCIN HYDROCHLORIDEKNACK PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL2022/02/15N / NDISCONTINUEDopenFDA ↗
A213059-003VANCOMYCIN HYDROCHLORIDEKNACK PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2022/02/15N / NDISCONTINUEDopenFDA ↗
A215195-001VANCOMYCIN HYDROCHLORIDEMEITHEAL PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 750MG BASE/VIAL2022/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215196-001VANCOMYCIN HYDROCHLORIDEMEITHEAL PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2022/07/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215196-002VANCOMYCIN HYDROCHLORIDEMEITHEAL PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2022/07/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215197-001VANCOMYCIN HYDROCHLORIDEMEITHEAL PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2022/07/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215197-002VANCOMYCIN HYDROCHLORIDEMEITHEAL PHARMACEUTICALS INCINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2022/07/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215821-001VANCOMYCIN HYDROCHLORIDEHAINAN POLY PHARM CO LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 5GM BASE/VIAL2021/11/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215821-002VANCOMYCIN HYDROCHLORIDEHAINAN POLY PHARM CO LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 10GM BASE/VIAL2021/11/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A216591-001VANCOMYCIN HYDROCHLORIDEASPIRO PHARMA LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 500MG BASE/VIAL2022/07/06N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A216591-002VANCOMYCIN HYDROCHLORIDEASPIRO PHARMA LTDINJECTABLEINJECTIONVANCOMYCIN HYDROCHLORIDE: EQ 1GM BASE/VIAL2022/07/06N / NHUMAN 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 12

Company (original)Identifier (original)Source dateOfficial source
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20265043See source2026/06/30Official source ↗
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20264232See source2026/05/07Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20255230See source2025/08/26Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20253781See source2025/04/01Official source ↗
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244955See source2024/09/19Official source ↗
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244808See source2024/09/03Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20243660See source2024/05/08Official source ↗
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20193378See source2023/04/05Official source ↗
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20084268See source2021/11/15Official source ↗
Zhejiang Pharmaceuticals Co., Ltd. romanized国药准字H20033366See source2021/06/03Official source ↗
VANCOCIN ITALIA S.R.L.H20140174500mg1988/10/15Official source ↗
YaoPharma Co., Ltd.国药准字H20254904See source2025/07/22Official source ↗

NHSA approval numbers 15

Company (original)Identifier (original)Source dateOfficial source
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20193378See source—Official source ↗
YaoPharma Co., Ltd.国药准字H20254904See source—Official source ↗
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H20255230See source—Official source ↗
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20264232See source—Official source ↗
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20084268See source—Official source ↗
Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized国药准字H20033366See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20253781See source—Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20243660See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20265043See source—Official source ↗
VANCOCIN ITALIA S.R.L.国药准字HJ20140174See source—Official source ↗
CJ HealthCare CorporationH20171132See source—Official source ↗
Gentle pharma Co.,Ltd.HC20150054See source—Official source ↗
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244808See source—Official source ↗
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H20244955See source—Official source ↗
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20193378See source—Official source ↗
Anhui Pioneer Pharmaceutical Co., Ltd国药准字H20264232See source—Official source ↗
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20084268See source—Official source ↗
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H20253781See source—Official source ↗
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20243660See source—Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20265043See source—Official source ↗
Gentle pharma Co.,Ltd.HC20150054See source—Official source ↗
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244808See source—Official source ↗
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244808See source—Official source ↗
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20084269See source—Official source ↗
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H20084269See source—Official source ↗

Under review 4

Company (original)Identifier (original)Source dateOfficial source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS26009572026/04/24Official source ↗
Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized; Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanizedCYHS26007262026/03/26Official source ↗
Shenzhen Li Jian Pharma Co., Ltd. romanizedCYHS26017662026/07/23Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS26006362026/03/10Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS26009572026/04/24Official source ↗
Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized; Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanizedCYHS26007262026/03/26Official source ↗
Shenzhen Li Jian Pharma Co., Ltd. romanizedCYHS26017662026/07/23Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS26006362026/03/10Official source ↗

API companies with A status 6

Company (original)Identifier (original)Source dateOfficial source
Zhejiang Chang Hai Pharmaceutical Co., Ltd. romanizedY202300002812025/03/06Official source ↗
Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY20190009487—Official source ↗
Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanizedY20190006976—Official source ↗
Zhejiang Hai Zheng Pharma Co., Ltd. romanizedY201900062632025/07/04Official source ↗
Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY201800012872025/03/18Official source ↗
Li Zhu Group Fuzhou Fu Xing Pharmaceuticals Co., Ltd. romanizedY201700002762026/09/03Official source ↗
Ya Sai Li (Tai Zhou) Pharmaceutical Co., Ltd. romanizedY201700001732024/10/22Official 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