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Furosemide Oral Solution

Matched
Active ingredients (original)
FUROSEMIDE
Dosage form (original)
SOLUTION
Route (original)
ORAL

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 applications3
RLD applicantSANOFI AVENTIS US LLC

Currently marketed products: 2 · 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
A070433-001FUROSEMIDEHIKMA PHARMACEUTICALS USA INCSOLUTIONORALFUROSEMIDE: 40MG/5ML1987/04/22N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A070434-001FUROSEMIDEHIKMA PHARMACEUTICALS USA INCSOLUTIONORALFUROSEMIDE: 10MG/ML1987/04/22N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A070655-001FUROSEMIDEPHARMOBEDIENT CONSULTINGSOLUTIONORALFUROSEMIDE: 10MG/ML1987/10/02N / NDISCONTINUEDopenFDA ↗
N017688-001LASIXSANOFI AVENTIS US LLCSOLUTIONORALFUROSEMIDE: 10MG/MLApproved 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 0

Company (original)Identifier (original)Source dateOfficial source
No matching records in this loaded source.

NHSA approval numbers 4

Company (original)Identifier (original)Source dateOfficial source
Jian Min Pharma Group Co., Ltd. romanized国药准字H2025519660ml∶0.6g—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H2024924260ml:0.6g—Official source ↗
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H2024315360ml∶0.6g—Official source ↗
Ren He Yi Kang Group Co., Ltd. romanized国药准字H2025355460ml:0.6g—Official source ↗

Under review 8

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanizedCYHS25037582025/10/22Official source ↗
Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS26008492026/04/13Official source ↗
Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanizedCYHS26004152026/02/10Official source ↗
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanizedCYHS25039732025/11/18Official source ↗
Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanizedCYHS25039722025/11/18Official source ↗
Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS25038592025/11/04Official source ↗
Hainan Quan Xing Pharmaceutical Co., Ltd. romanizedCYHS25016982025/05/10Official source ↗
Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanizedCYHS25010542025/03/14Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Lian Huan Pharma (An Qing) Co., Ltd. romanizedCYHS26012642026/06/04Official source ↗
Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS26008492026/04/13Official source ↗
Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanizedCYHS26004152026/02/10Official source ↗

API companies with A status 20

Company (original)Identifier (original)Source dateOfficial source
Huang Shi Fu Er Tai Pharmaceuticals Technology Co., Ltd. romanizedY202500001552026/07/14Official source ↗
Yun Peng Pharmaceuticals Group Co., Ltd. romanizedY202500000262026/06/11Official source ↗
Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY202400013962026/06/11Official source ↗
Hebei Guo Long Pharmaceutical Co., Ltd. romanizedY202400015162026/07/21Official source ↗
SRI KRISHNA PHARMACEUTICALS LIMITED UNIT IVY202300011182026/07/21Official source ↗
Sichuan Sheng Yu Xin Pharma Co., Ltd. romanizedY202400001252025/07/28Official source ↗
Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanizedY202300003112026/10/21Official source ↗
Sui Cheng Pharma Co., Ltd. romanizedY202300002522024/06/12Official source ↗
Hunan Ou Ya Pharma Co., Ltd. romanizedY202200005662026/04/08Official source ↗
Henan Jing Kang Pharmaceutical Co., Ltd. romanizedY202200003202024/09/20Official source ↗
Mangalam Drugs and Organics Ltd.Y202000008352026/10/15Official source ↗
Assia Chemical Industries Ltd.Y202000011662025/05/17Official source ↗
Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanizedY20219990005—Official source ↗
Curia India Private LimitedY201900090972025/06/03Official source ↗
Changzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY201900087222025/07/24Official source ↗
Beijing Tai Yang Pharma Co., Ltd. romanizedY20190005487—Official source ↗
Dong Bei Pharmaceutical Group Co., Ltd. romanizedY201900037992024/04/24Official source ↗
Tai Shan Shi Xin Ning Pharmaceutical Co., Ltd. romanizedY201900027972026/02/27Official source ↗
Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanizedY201900021952023/04/23Official source ↗
Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanizedY201900021392026/03/04Official source ↗
Ipca Laboratories LimitedY201700000882024/06/27Official 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 SOLUTION / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-028. Chinese Pharmacopoeia general chapter 0123

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

Name and dosage-form matching sources