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Erythromycin Lactobionate for Injection

Matched
Active ingredients (original)
ERYTHROMYCIN LACTOBIONATE
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 applications9
RLD applicantHOSPIRA INC

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
A062563-001ERYTHROMYCINELKINS SINN DIV AH ROBINS CO INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1985/03/28N / NDISCONTINUEDopenFDA ↗
A062563-002ERYTHROMYCINELKINS SINN DIV AH ROBINS CO INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1985/03/28N / NDISCONTINUEDopenFDA ↗
A062586-001ERYTHROCINABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1988/01/04N / NDISCONTINUEDopenFDA ↗
A062586-002ERYTHROCINABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1988/01/04N / NDISCONTINUEDopenFDA ↗
A062604-001ERYTHROMYCIN LACTOBIONATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1986/11/24N / NDISCONTINUEDopenFDA ↗
A062604-002ERYTHROMYCIN LACTOBIONATEABRAXIS PHARMACEUTICAL PRODUCTSINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1986/11/24N / NDISCONTINUEDopenFDA ↗
A062638-001ERYTHROCINHOSPIRA INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1986/10/31N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A062638-002ERYTHROCINHOSPIRA INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1986/10/31N / NDISCONTINUEDopenFDA ↗
A062993-001ERYTHROMYCIN LACTOBIONATEBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1989/05/09N / NDISCONTINUEDopenFDA ↗
A062993-002ERYTHROMYCIN LACTOBIONATEBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1989/05/09N / NDISCONTINUEDopenFDA ↗
A063253-001ERYTHROMYCIN LACTOBIONATETEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1993/07/30N / NDISCONTINUEDopenFDA ↗
A063253-002ERYTHROMYCIN LACTOBIONATETEVA PARENTERAL MEDICINES INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1993/07/30N / NDISCONTINUEDopenFDA ↗
A211086-001ERYTHROMYCIN LACTOBIONATEEXELA PHARMA SCIENCES LLCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL2020/09/17N / NDISCONTINUEDopenFDA ↗
A215290-001ERYTHROMYCIN LACTOBIONATENEXUS PHARMACEUTICALS LLCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL2022/02/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A216761-001ERYTHROMYCIN LACTOBIONATEGLAND PHARMA LTDINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL2024/11/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N050182-002ERYTHROCINHOSPIRA INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
N050182-003ERYTHROCINHOSPIRA INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
N050609-001ERYTHROCINHOSPIRA INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 500MG BASE/VIAL1986/09/24Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N050609-002ERYTHROCINHOSPIRA INCINJECTABLEINJECTIONERYTHROMYCIN LACTOBIONATE: EQ 1GM BASE/VIAL1986/09/24Y / 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 4

Company (original)Identifier (original)Source dateOfficial source
Guangdong Yue He Ze Drug Research Co., Ltd. romanized国药准字H20265708See source2026/08/25Official source ↗
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265577See source2026/08/04Official source ↗
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265578See source2026/08/04Official source ↗
Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized国药准字H20263149See source2026/01/20Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020028See source2026/10/16Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20269253See source2026/10/16Official source ↗

NHSA approval numbers 30

Company (original)Identifier (original)Source dateOfficial source
Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized国药准字H31021503See source—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H21021678See source—Official source ↗
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020871See source—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H51023236See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See source—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H14020379See source—Official source ↗
Shanxi Shuang Yan Pharma Co., Ltd. romanized国药准字H14020729See source—Official source ↗
Ha Yao Group Pharmaceutical Factory romanized国药准字H23021442See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020028See source—Official source ↗
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized国药准字H45021339See source—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021156See source—Official source ↗
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265578See source—Official source ↗
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized国药准字H20263854See source—Official source ↗
Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized国药准字H20263149See source—Official source ↗
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020871See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See source—Official source ↗
Hubei Mei Lin Pharma Co., Ltd. romanized国药准字H14020379See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H34023638See source—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021156See source—Official source ↗
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265578See source—Official source ↗
Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized国药准字H20263149See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See source—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H21021679See source—Official source ↗
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020872See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See source—Official source ↗
Shanxi Shuang Yan Pharma Co., Ltd. romanized国药准字H14022626See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H34023637See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020027See source—Official source ↗
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized国药准字H45021338See source—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021155See source—Official source ↗
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265577See source—Official source ↗
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized国药准字H20263855See source—Official source ↗
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H42020872See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020027See source—Official source ↗
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H20265577See source—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H21021678See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See source—Official source ↗
Guo Yao Group Guo Rui Pharma Co., Ltd. romanized国药准字H34023638See source—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H43020028See source—Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized国药准字H36021155See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See source—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H21021679See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022364See source—Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanized国药准字H61022363See source—Official source ↗
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H51023235See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053846See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053846See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053847See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053847See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053846See source—Official source ↗
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20053847See source—Official source ↗
Xian Di Sai Bio Pharma Co., Ltd. romanized国药准字H61021775See source—Official source ↗
Guangdong Yue He Ze Drug Research Co., Ltd. romanized国药准字H20265708See source—Official source ↗

Under review 13

Company (original)Identifier (original)Source dateOfficial source
Suzhou Erye Pharmaceutical Co., LtdCYHS25044722025/12/30Official source ↗
Suzhou Erye Pharmaceutical Co., LtdCYHS25044712025/12/30Official source ↗
Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanizedCYHS26018572026/08/03Official source ↗
Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCYHS25024902025/07/12Official source ↗
Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCYHS25024892025/07/12Official source ↗
Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanizedCYHS25007342025/02/13Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanizedCYHB26501372026/06/16Official source ↗
Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanizedCYHB26501362026/06/16Official source ↗
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS26007952026/04/08Official source ↗
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS26007942026/04/08Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS25032782025/09/05Official source ↗
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS25032772025/09/05Official source ↗
Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Haikou Qi Li Pharmaceutical Co., Ltd. romanizedCYHS25026752025/07/24Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanizedCYHS26018572026/08/03Official source ↗
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS26007952026/04/08Official source ↗
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS26007942026/04/08Official source ↗

API companies with A status 4

Company (original)Identifier (original)Source dateOfficial source
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedY202300012642025/10/23Official source ↗
Xian Li Jun Pharmaceutical Co., Ltd. romanizedY201900056702026/01/07Official source ↗
Huang Shi Huang Kang Pharma Co., Ltd. romanizedY20190004886—Official source ↗
Mei Luo Pharma Co., Ltd. romanizedY201900042022025/01/16Official 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