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Lactulose Oral Solution

Matched
Active ingredients (original)
LACTULOSE
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 applications19
RLD applicantSANOFI AVENTIS US LLC

Currently marketed products: 8 · 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
A070288-001CONSTULOSEACTAVIS MID ATLANTIC LLCSOLUTIONORALLACTULOSE: 10GM/15ML1988/08/15N / NDISCONTINUEDopenFDA ↗
A071054-001CONSTILACALRA LABORATORIES INCSOLUTIONORALLACTULOSE: 10GM/15ML1988/07/26N / NDISCONTINUEDopenFDA ↗
A071841-001LACTULOSEMORTON GROVE PHARMACEUTICALS INCSOLUTIONORALLACTULOSE: 10GM/15ML1988/09/22N / NDISCONTINUEDopenFDA ↗
A072372-001DUPHALACSOLVAY PHARMACEUTICALSSOLUTIONORALLACTULOSE: 10GM/15ML1989/03/22N / NDISCONTINUEDopenFDA ↗
A073160-001LACTULOSEPACO PHARMACEUTICAL SERVICES INCSOLUTIONORALLACTULOSE: 10GM/15ML1992/08/25N / NDISCONTINUEDopenFDA ↗
A073497-001EVALOSETEVA PHARMACEUTICALS USASOLUTIONORALLACTULOSE: 10GM/15ML1993/05/28N / NDISCONTINUEDopenFDA ↗
A073591-001LACTULOSEHIKMA PHARMACEUTICALS USA INCSOLUTIONORALLACTULOSE: 10GM/15ML1992/05/29N / NDISCONTINUEDopenFDA ↗
A073686-001LAXILOSENOSTRUM LABORATORIES INCSOLUTIONORALLACTULOSE: 10GM/15ML1993/05/28N / NDISCONTINUEDopenFDA ↗
A074076-001LACTULOSEHIKMA PHARMACEUTICALS USA INCSOLUTIONORALLACTULOSE: 10GM/15ML1995/07/03N / NDISCONTINUEDopenFDA ↗
A074138-001LACTULOSEVISTAPHARM LLCSOLUTIONORALLACTULOSE: 10GM/15ML1992/09/30N / NDISCONTINUEDopenFDA ↗
A074602-001LACTULOSEAUROBINDO PHARMA LTDSOLUTIONORALLACTULOSE: 10GM/15ML1996/11/14N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A074623-001LACTULOSEPHARMACEUTICAL ASSOCIATES INCSOLUTIONORALLACTULOSE: 10GM/15ML1996/07/30N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
A075911-001LACTULOSEPHARMOBEDIENT CONSULTING LLCSOLUTIONORALLACTULOSE: 10GM/15ML2002/02/21N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A075993-001LACTULOSELANNETT CO INCSOLUTIONORALLACTULOSE: 10GM/15ML2001/07/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A078430-001LACTULOSEANI PHARMACEUTICALS INCSOLUTIONORALLACTULOSE: 10GM/15ML2007/11/28N / NDISCONTINUEDopenFDA ↗
A090503-001LACTULOSEFRESENIUS KABI AUSTRIA GMBHSOLUTIONORALLACTULOSE: 10GM/15ML2012/01/25N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207786-001LACTULOSEPHARMAZONESOLUTIONORALLACTULOSE: 10GM/15ML2018/06/11N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A209517-001LACTULOSECHARTWELL RX SCIENCES LLCSOLUTIONORALLACTULOSE: 10GM/15ML2018/11/23N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A218858-001LACTULOSETARO PHARMACEUTICAL INDUSTRIES LTDSOLUTIONORALLACTULOSE: 10GM/15ML2024/12/13N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N017884-001CHRONULACSANOFI AVENTIS US LLCSOLUTIONORALLACTULOSE: 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Approved 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 1

Company (original)Identifier (original)Source dateOfficial source
Abbott Healthcare Products B.V.H20171057667mg/ml 1996/06/25Official source ↗

NHSA approval numbers 112

Company (original)Identifier (original)Source dateOfficial source
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H20264429200ml:133.4g—Official source ↗
Jiangxi Hai Er Si Pharma Co., Ltd. romanized国药准字H2026306215ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized国药准字H2026320215ml:10g—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H2026308415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H20265379200ml:133.4g—Official source ↗
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20263308100ml :66.7g—Official source ↗
Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized国药准字H2026359915ml:10g—Official source ↗
Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20264134200ml:133.4g—Official source ↗
Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized国药准字H2026376215ml:10g—Official source ↗
Fujian Sheng Rong Heng Pharmaceuticals Co., Ltd. romanized国药准字H20265345100ml:66.7g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized国药准字H2026320215ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized国药准字H2026376215ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10g—Official source ↗
Jiangxi Hai Er Si Pharma Co., Ltd. romanized国药准字H20263063200ml:133.4g—Official source ↗
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H20265145200ml:133.4g—Official source ↗
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H2026308415ml:10g—Official source ↗
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H2026537815ml: 10g—Official source ↗
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H2026330715ml:10g—Official source ↗
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H20264284200ml:133.4g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3g—Official source ↗
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H2026330715ml:10g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3g—Official source ↗
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H202642855ml:3.3g—Official source ↗
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H20264286100ml:66.7g—Official source ↗
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H2026428715ml:10g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H20269132100ml:66.7g—Official source ↗
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H20256361200ml:133.4g—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H20258288200ml:133.4g—Official source ↗
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H2025640715ml:10g—Official source ↗
Yun Peng Pharmaceuticals Group Co., Ltd. romanized国药准字H2025365715ml:10g—Official source ↗
Ha Yao Group Zhong Yao Er Factory romanized国药准字H2025380515mL:10g—Official source ↗
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H2025315715ml:10g—Official source ↗
Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2025537215ml:10g—Official source ↗
Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized国药准字H2025542915ml:10g—Official source ↗
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H202547575ml:3.3g—Official source ↗
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253347200ml:133.4g—Official source ↗
Qingdao Ge En Pharmaceutical Co., Ltd. romanized国药准字H2025348415ml:10g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10g—Official source ↗
Chongqing Jian Neng Pharma Group Co., Ltd. romanized国药准字H20253369100ml:66.7g—Official source ↗
Le Fu Si Health Industry Shareholding Company romanized国药准字H2025471815ml:10g—Official source ↗
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H2025307515ml:10g—Official source ↗
Hubei Mei Si Chuang Pharma Co., Ltd. romanized国药准字H20253366100ml:66.7g—Official source ↗
Beijing Han Mei Bio Technology Co., Ltd. romanized国药准字H20253514100ml:66.7g—Official source ↗
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254719100ml:66.7g—Official source ↗
Hunan Ji Zheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025571415ml:10g—Official source ↗
Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025538315ml:10g—Official source ↗
Chengdu Ke Lai Meng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255718200ml:133.4g—Official source ↗
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H2025640715ml:10g—Official source ↗
Yun Peng Pharmaceuticals Group Co., Ltd. romanized国药准字H2025365715ml:10g—Official source ↗
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H2025315715ml:10g—Official source ↗
Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized国药准字H2025542915ml:10g—Official source ↗
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H202547575ml:3.3g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10g—Official source ↗
Le Fu Si Health Industry Shareholding Company romanized国药准字H2025471815ml:10g—Official source ↗
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H2025307515ml:10g—Official source ↗
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H2025640715ml:10g—Official source ↗
Yun Peng Pharmaceuticals Group Co., Ltd. romanized国药准字H2025365715ml:10g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10g—Official source ↗
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H20256360100ml:66.7g—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H20253985100ml: 66.7g—Official source ↗
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20256408200ml:133.4g—Official source ↗
Ha Yao Group Zhong Yao Er Factory romanized国药准字H2025380515mL:10g—Official source ↗
Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H20255373200ml:133.4g—Official source ↗
Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized国药准字H20255430200ml:133.4g—Official source ↗
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H20254758200ml:133.4g—Official source ↗
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253348100ml:66.7g—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10g—Official source ↗
Chongqing Jian Neng Pharma Group Co., Ltd. romanized国药准字H2025337015ml:10g—Official source ↗
Beijing Han Mei Bio Technology Co., Ltd. romanized国药准字H2025403515ml:10g—Official source ↗
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254720200ml:133.4g—Official source ↗
Hunan Ji Zheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255715200ml:133.4g—Official source ↗
Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255382200ml:133.4g—Official source ↗
Chengdu Ke Lai Meng Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025571915ml:10g—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H202582875ml:3.3g—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H2025829060ml:40.02g—Official source ↗
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025334915ml:10g—Official source ↗
Hunan Ji Zheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025571415ml:10g—Official source ↗
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025334915ml:10g—Official source ↗
Mei Luo Pharma Co., Ltd. romanized国药准字H2025828615ml:10g—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20258291100ml:66.7g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H20253168200ml:133.4g—Official source ↗
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%—Official source ↗
Jian Min Pharma Group Co., Ltd. romanized国药准字H20244664200ml:133.4g—Official source ↗
Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized国药准字H2010362160ml:40.02g—Official source ↗
Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized国药准字H10890034100ml:50g—Official source ↗
Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized国药准字H2024942315ml:10g—Official source ↗
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized国药准字H2024955815ml:10g—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10g—Official source ↗
Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanized国药准字H2007400910ml:5g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H20234275200ml:133.4g—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20093523100ml:66.7g—Official source ↗
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10g—Official source ↗
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20249475200ml:133.4g—Official source ↗
Fresenius Kabi Austria GmbHH20160470100ml:67g—Official source ↗
Abbott B.V.国药准字HJ20171057667mg/ml—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Su Zhou Yi Fan Pharma Co., Ltd. romanized国药准字J20170046100ml: 67g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)—Official source ↗
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10g—Official source ↗
Bao Ding Ai Hui Pharma Co., Ltd. romanized国药准字H20249742200ml:133.4g—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10g—Official source ↗
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H20243526100ml:66.7g—Official source ↗
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H2024934215ml:10g—Official source ↗
Jiangsu Yue Xing Pharma Co., Ltd. romanized国药准字H20249283200ml:133.4g—Official source ↗
Hainan Mei Kang Da Pharma Co., Ltd. romanized国药准字H2024371315ml:10g—Official source ↗
Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024979515ml:10g—Official source ↗
Hua Run Jiang Zhong Pharma Co., Ltd. romanized国药准字H2024422715ml:10g—Official source ↗
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024462315ml:10g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H20244825200ml:133.4g—Official source ↗
Hua Cui International Bio Technology (Guangdong) Co., Ltd. romanized国药准字H20249304100ml:66.7g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%—Official source ↗
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized国药准字H2024955815ml:10g—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10g—Official source ↗
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10g—Official source ↗
Yunnan Kang Jian Shan Mei Pharmaceutical Co., Ltd. romanized国药准字H53020078100ml:50g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)—Official source ↗
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10g—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10g—Official source ↗
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H2024934215ml:10g—Official source ↗
Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024979515ml:10g—Official source ↗
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024462315ml:10g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10g—Official source ↗
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)—Official source ↗
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10g—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10g—Official source ↗
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)—Official source ↗
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10g—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10g—Official source ↗
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)—Official source ↗
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10g—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10g—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H20093300100ml:50g—Official source ↗
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%—Official source ↗
Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized国药准字H2010362160ml:40.02g—Official source ↗
Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized国药准字H10890034100ml:50g—Official source ↗
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H20249750100ml:66.7g—Official source ↗
Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanized国药准字H20074010100ml:50g—Official source ↗
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20093524250ml:166.8g—Official source ↗
Fresenius Kabi Austria GmbHH20160470100ml:67g—Official source ↗
Abbott B.V.国药准字HJ20171057667mg/ml—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H20234274100ml:66.7g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)—Official source ↗
Suzhou Erye Pharmaceutical Co., Ltd国药准字H20249348200ml:133.4g—Official source ↗
Hainan Mei Kang Da Pharma Co., Ltd. romanized国药准字H20243714100ml:66.7g—Official source ↗
Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized国药准字H202497965ml:3.3g—Official source ↗
Hua Run Jiang Zhong Pharma Co., Ltd. romanized国药准字H20244228200ml:133.4g—Official source ↗
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244624200ml:133.4g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10g—Official source ↗
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized国药准字H2010362160ml:40.02g—Official source ↗
Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanized国药准字H2007400910ml:5g—Official source ↗
Fresenius Kabi Austria GmbH国药准字HJ2017015215ml:10g—Official source ↗
Abbott B.V.国药准字HJ20171057667mg/ml—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10g—Official source ↗
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)—Official source ↗
Hua Run Jiang Zhong Pharma Co., Ltd. romanized国药准字H2024422715ml:10g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Fresenius Kabi Austria GmbH国药准字HJ2017015215ml:10g—Official source ↗
Abbott B.V.国药准字HJ20171057667mg/ml—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10g—Official source ↗
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5g—Official source ↗
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7g—Official source ↗
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H20093300100ml:50g—Official source ↗
Fresenius Kabi Austria GmbH国药准字HJ20170248100ml:67g—Official source ↗
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10g—Official source ↗
Fresenius Kabi Austria GmbH国药准字HJ20160470100ml:67g—Official source ↗
Fresenius Kabi Austria GmbH国药准字HJ20160470100ml:67g—Official source ↗
Fujian Sheng Rong Heng Pharmaceuticals Co., Ltd. romanized国药准字H2026445715ml:10g—Official source ↗

Under review 34

Company (original)Identifier (original)Source dateOfficial source
Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized; Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanizedCYHS26005202026/02/25Official source ↗
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS26020642026/08/20Official source ↗
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS26020632026/08/20Official source ↗
Jiangsu Yue Xing Pharma Co., Ltd. romanizedCYHB25013712025/07/10Official source ↗
Jiangsu Shen Hua Pharma Co., Ltd. romanizedCYHS25042082025/12/06Official source ↗
Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanizedCYHS25042682025/12/12Official source ↗
Hainan Si Da Pharmaceutical Co., Ltd. romanizedCYHB26019062026/10/19Official source ↗
Hainan Si Da Pharmaceutical Co., Ltd. romanizedCYHB26019052026/10/19Official source ↗
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS26022652026/09/10Official source ↗
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS26021862026/09/02Official source ↗
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS26021852026/09/02Official source ↗
Zhejiang Guo Jing Pharma Co., Ltd. romanizedCYHS26019872026/08/13Official source ↗
Jiangxi Shimei Pharmaceutical Co., LtdCYHS26019592026/08/10Official source ↗
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS26015472026/07/01Official source ↗
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS26015462026/07/01Official source ↗
Hubei Mei Si Chuang Pharma Co., Ltd. romanizedCYHB26011152026/06/12Official source ↗
Hubei Mei Si Chuang Pharma Co., Ltd. romanizedCYHB26011082026/06/12Official source ↗
Henan Ling Rui Pharmaceutical Co., Ltd. romanizedCYHS26006462026/03/12Official source ↗
Zhejiang Jin Li Yuan Pharma Co., Ltd. romanizedCYHS26003222026/01/31Official source ↗
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS25042522025/12/11Official source ↗
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS25042512025/12/11Official source ↗
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS25042502025/12/11Official source ↗
Jiangxi Yao Dou Ren He Pharmaceutical Co., Ltd. romanizedCYHS25039842025/11/18Official source ↗
Tianjin He Zhi Pharma Group Co., Ltd. romanizedCYHS25033472025/09/10Official source ↗
Tianjin He Zhi Pharma Group Co., Ltd. romanizedCYHS25033462025/09/10Official source ↗
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedCYHS25029852025/08/15Official source ↗
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedCYHS25029842025/08/15Official source ↗
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedCYHS25029822025/08/15Official source ↗
Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCYHS25028962025/08/09Official source ↗
Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCYHS25028952025/08/09Official source ↗
Wuhan An Cheng Pharmaceuticals Co., Ltd. romanized; Hubei Ji An Tang Pharma Co., Ltd. romanizedCYHS25018382025/05/22Official source ↗
Beijing Jin Dian Han Fang Pharma Co., Ltd. romanizedCYHS25015582025/04/25Official source ↗
Henan Tai Feng Bio Technology Co., Ltd. romanizedCYHS25014512025/04/16Official source ↗
Hubei Wu Shi Pharma Co., Ltd. romanizedCYHS25011682025/03/25Official source ↗

Generic-filing companies this year 9

Company (original)Identifier (original)Source dateOfficial source
Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized; Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanizedCYHS26005202026/02/25Official source ↗
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS26020642026/08/20Official source ↗
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS26020632026/08/20Official source ↗
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS26022652026/09/10Official source ↗
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS26021862026/09/02Official source ↗
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS26021852026/09/02Official source ↗
Zhejiang Guo Jing Pharma Co., Ltd. romanizedCYHS26019872026/08/13Official source ↗
Jiangxi Shimei Pharmaceutical Co., LtdCYHS26019592026/08/10Official source ↗
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS26015472026/07/01Official source ↗
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS26015462026/07/01Official source ↗
Henan Ling Rui Pharmaceutical Co., Ltd. romanizedCYHS26006462026/03/12Official source ↗
Zhejiang Jin Li Yuan Pharma Co., Ltd. romanizedCYHS26003222026/01/31Official source ↗

API companies with A status 1

Company (original)Identifier (original)Source dateOfficial source
Fresenius Kabi Austria GmbHY201700010962025/10/15Official 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.

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

Name and dosage-form matching sources