YaoGeJu

← Back to list

Calcitonin Salmon Injection

Matched
Active ingredients (original)
CALCITONIN SALMON
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 applicantMYLAN IRELAND LTD / SANOFI AVENTIS US LLC

Currently marketed products: 9 · 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
A073690-001CALCITONIN-SALMONIGI LABORATORIES INCINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML1995/04/14N / NDISCONTINUEDopenFDA ↗
A209358-001CALCITONIN-SALMONPH HEALTH LTDINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2021/11/10N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212416-001CALCITONIN-SALMONCUSTOPHARM INCINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2021/05/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212675-001CALCITONIN-SALMONFRESENIUS KABI USA LLCINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2024/12/05N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A213766-001CALCITONIN-SALMONCIPLA LTDINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2024/09/20N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215715-001CALCITONIN-SALMONDR REDDYS LABORATORIES LTDINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2024/04/11N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215864-001CALCITONIN-SALMONZYDUS PHARMACEUTICALS USA INCINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2026/03/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A216294-001CALCITONIN-SALMONAMNEAL EU LTDINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2025/09/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A219196-001CALCITONIN-SALMONSAGENT PHARMACEUTICALSINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML2025/07/09N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N017497-001CALCIMARSANOFI AVENTIS US LLCINJECTABLEINJECTIONCALCITONIN SALMON: 400 IU/VIALApproved before 1982N / NDISCONTINUEDopenFDA ↗
N017769-001CALCIMARSANOFI AVENTIS US LLCINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved before 1982Y / NDISCONTINUEDopenFDA ↗
N017808-001MIACALCINMYLAN IRELAND LTDINJECTABLEINJECTIONCALCITONIN SALMON: 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1986/07/03Y / NDISCONTINUEDopenFDA ↗
N017808-002MIACALCINMYLAN IRELAND LTDINJECTABLEINJECTIONCALCITONIN SALMON: 200 IU/ML1991/03/29Y / 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 1

Company (original)Identifier (original)Source dateOfficial source
Future Health Pharma GmbHH201702031ml: 50IU1996/01/15Official source ↗

NHSA approval numbers 10

Company (original)Identifier (original)Source dateOfficial source
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200700841ml:16.7μg(100IU)—Official source ↗
Beijing SL Pharmaceutical Co., Ltd.国药准字H200206941ml:8.3μg(50IU)—Official source ↗
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200403031ml:50IU—Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H201134031ml:100IU—Official source ↗
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200103611ml:8.3μg(50IU)—Official source ↗
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字J201501231ml:50IU—Official source ↗
Future Health Pharma GmbH国药准字HJ201702031ml:50IU—Official source ↗
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200700841ml:16.7μg(100IU)—Official source ↗
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200403031ml:50IU—Official source ↗
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H201133061ml:50IU—Official source ↗
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字J201501231ml:50IU—Official source ↗
Future Health Pharma GmbH国药准字HJ201702031ml:50IU—Official source ↗
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200403031ml:50IU—Official source ↗
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200404951ml:8.3μg(50IU)—Official source ↗
Beijing SL Pharmaceutical Co., Ltd.国药准字H200600562ml:20μg—Official source ↗
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200103611ml:8.3μg(50IU)—Official source ↗
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200404951ml:8.3μg(50IU)—Official source ↗
Beijing SL Pharmaceutical Co., Ltd.国药准字H200600562ml:20μg—Official source ↗
Beijing SL Pharmaceutical Co., Ltd.国药准字H200206941ml:8.3μg(50IU)—Official source ↗

Under review 5

Company (original)Identifier (original)Source dateOfficial source
Yin Gu Pharmaceutical Co., Ltd. romanizedCYHB26501272026/05/28Official source ↗
Yin Gu Pharmaceutical Co., Ltd. romanizedCYHB26501262026/05/28Official source ↗
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanizedCYHS26000782026/01/08Official source ↗
Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS26000702026/01/08Official source ↗
Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanizedCYHS25023812025/07/05Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanizedCYHS26000782026/01/08Official source ↗
Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS26000702026/01/08Official source ↗

API companies with A status 7

Company (original)Identifier (original)Source dateOfficial source
Han Yu Pharma (Wuhan) Co., Ltd. romanizedY202200003432024/06/28Official source ↗
Beijing SL Pharmaceutical Co., Ltd.Y20190005817—Official source ↗
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanizedY201900054832025/01/03Official source ↗
Gui Lin Nan Yao Co., Ltd. romanizedY201900040832025/01/18Official source ↗
Shenzhen Han Yu Pharma Co., Ltd. romanizedY201900027192024/01/17Official source ↗
Shanghai Su Hao Yi Ming Pharmaceutical Co., Ltd. romanizedY201900024402025/05/24Official source ↗
Qingdao Guo Da Biopharmaceutical Co., Ltd. romanizedY201900016522025/01/16Official 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-076. Chinese Pharmacopoeia general chapter 0102

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

Name and dosage-form matching sources