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Public drug landscapesDrug landscape

Lactulose Oral Solution

As of 13 November 2026, for Lactulose Oral Solution, 34 applications are listed as under review at China's CDE; 9 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

Companies, stages and changes, with each record available on this page.

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 2 of 2 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Oral Solution. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
CHRONULAC SANOFI AVENTIS US LLC NDA 017884 · Product no. 001 SOLUTION ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
CEPHULAC SANOFI AVENTIS US LLC NDA 017657 · Product no. 001 SOLUTION ORAL, RECTAL DISCONTINUED Approved prior to 1982 (exact date not listed)

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

Chemical-drug catalogue

Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Abbott Healthcare Products B.V.Abbott Biologicals B.V.H201710571996/06/25667mg/ml Imported originator drugCDE

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

NHSA drug codes

Loaded records: 112 distinct approval numbers and 67 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H20264429200ml:133.4gCategory BXA06ADR050X001010104960NHSA
Jiangxi Hai Er Si Pharma Co., Ltd. romanized国药准字H2026306215ml:10gCategory BXA06ADR050X001010105291NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010105355NHSA
Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized国药准字H2026320215ml:10gCategory BXA06ADR050X001010109207NHSA
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H2026308415ml:10gCategory BXA06ADR050X001010180537NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010183191NHSA
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H20265379200ml:133.4gCategory BXA06ADR050X001010183356NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20263308100ml :66.7gCategory BXA06ADR050X001010183611NHSA
Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized国药准字H2026359915ml:10gCategory BXA06ADR050X001010183642NHSA
Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20264134200ml:133.4gCategory BXA06ADR050X001010183926NHSA
Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized国药准字H2026376215ml:10gCategory BXA06ADR050X001010184209NHSA
Fujian Sheng Rong Heng Pharmaceuticals Co., Ltd. romanized国药准字H20265345100ml:66.7gCategory BXA06ADR050X001010184977NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010205355NHSA
Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized国药准字H2026320215ml:10gCategory BXA06ADR050X001010209207NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010283191NHSA
Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized国药准字H2026376215ml:10gCategory BXA06ADR050X001010284209NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010305355NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010383191NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010405355NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010483191NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010505355NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010583191NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010605355NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010683191NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010705355NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010783191NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H2026514415ml:10gCategory BXA06ADR050X001010805355NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010883191NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001010983191NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001011083191NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H2026474615ml:10gCategory BXA06ADR050X001011183191NHSA
Jiangxi Hai Er Si Pharma Co., Ltd. romanized国药准字H20263063200ml:133.4gCategory BXA06ADR050X001020105291NHSA
Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized国药准字H20265145200ml:133.4gCategory BXA06ADR050X001020105355NHSA
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H2026308415ml:10gCategory BXA06ADR050X001020180537NHSA
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H2026537815ml: 10gCategory BXA06ADR050X001020183356NHSA
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H2026330715ml:10gCategory BXA06ADR050X001030101001NHSA
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H20264284200ml:133.4gCategory BXA06ADR050X001030102471NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3gCategory BXA06ADR050X001030183595NHSA
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H2026330715ml:10gCategory BXA06ADR050X001030201001NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3gCategory BXA06ADR050X001030283595NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3gCategory BXA06ADR050X001030383595NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H202631025ml:3.3gCategory BXA06ADR050X001030483595NHSA
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H202642855ml:3.3gCategory BXA06ADR050X001040102471NHSA
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H20264286100ml:66.7gCategory BXA06ADR050X001050102471NHSA
Shaanxi Xing Bang Pharma Co., Ltd. romanized国药准字H2026428715ml:10gCategory BXA06ADR050X001060102471NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20269132100ml:66.7gCategory BXA06ADR050X001060180651NHSA
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H20256361200ml:133.4gCategory BXA06ADR050X001010101001NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H20258288200ml:133.4gCategory BXA06ADR050X001010101122NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H2025640715ml:10gCategory BXA06ADR050X001010101503NHSA
Yun Peng Pharmaceuticals Group Co., Ltd. romanized国药准字H2025365715ml:10gCategory BXA06ADR050X001010102968NHSA
Ha Yao Group Zhong Yao Er Factory romanized国药准字H2025380515mL:10gCategory BXA06ADR050X001010103714NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H2025315715ml:10gCategory BXA06ADR050X001010104111NHSA
Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2025537215ml:10gCategory BXA06ADR050X001010104873NHSA
Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized国药准字H2025542915ml:10gCategory BXA06ADR050X001010105237NHSA
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H202547575ml:3.3gCategory BXA06ADR050X001010182338NHSA
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253347200ml:133.4gCategory BXA06ADR050X001010183056NHSA
Qingdao Ge En Pharmaceutical Co., Ltd. romanized国药准字H2025348415ml:10gCategory BXA06ADR050X001010183584NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10gCategory BXA06ADR050X001010183595NHSA
Chongqing Jian Neng Pharma Group Co., Ltd. romanized国药准字H20253369100ml:66.7gCategory BXA06ADR050X001010183692NHSA
Le Fu Si Health Industry Shareholding Company romanized国药准字H2025471815ml:10gCategory BXA06ADR050X001010183955NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H2025307515ml:10gCategory BXA06ADR050X001010184482NHSA
Hubei Mei Si Chuang Pharma Co., Ltd. romanized国药准字H20253366100ml:66.7gCategory BXA06ADR050X001010184577NHSA
Beijing Han Mei Bio Technology Co., Ltd. romanized国药准字H20253514100ml:66.7gCategory BXA06ADR050X001010184761NHSA
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254719100ml:66.7gCategory BXA06ADR050X001010184778NHSA
Hunan Ji Zheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025571415ml:10gCategory BXA06ADR050X001010184994NHSA
Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025538315ml:10gCategory BXA06ADR050X001010185010NHSA
Chengdu Ke Lai Meng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255718200ml:133.4gCategory BXA06ADR050X001010185240NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H2025640715ml:10gCategory BXA06ADR050X001010201503NHSA
Yun Peng Pharmaceuticals Group Co., Ltd. romanized国药准字H2025365715ml:10gCategory BXA06ADR050X001010202968NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H2025315715ml:10gCategory BXA06ADR050X001010204111NHSA
Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized国药准字H2025542915ml:10gCategory BXA06ADR050X001010205237NHSA
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H202547575ml:3.3gCategory BXA06ADR050X001010282338NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10gCategory BXA06ADR050X001010283595NHSA
Le Fu Si Health Industry Shareholding Company romanized国药准字H2025471815ml:10gCategory BXA06ADR050X001010283955NHSA
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H2025307515ml:10gCategory BXA06ADR050X001010284482NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H2025640715ml:10gCategory BXA06ADR050X001010301503NHSA
Yun Peng Pharmaceuticals Group Co., Ltd. romanized国药准字H2025365715ml:10gCategory BXA06ADR050X001010302968NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10gCategory BXA06ADR050X001010383595NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10gCategory BXA06ADR050X001010483595NHSA
Chongqing He Ping Pharmaceutical Co., Ltd. romanized国药准字H20256360100ml:66.7gCategory BXA06ADR050X001020101001NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H20253985100ml: 66.7gCategory BXA06ADR050X001020101122NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20256408200ml:133.4gCategory BXA06ADR050X001020101503NHSA
Ha Yao Group Zhong Yao Er Factory romanized国药准字H2025380515mL:10gCategory BXA06ADR050X001020103714NHSA
Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H20255373200ml:133.4gCategory BXA06ADR050X001020104873NHSA
Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized国药准字H20255430200ml:133.4gCategory BXA06ADR050X001020105237NHSA
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H20254758200ml:133.4gCategory BXA06ADR050X001020182338NHSA
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253348100ml:66.7gCategory BXA06ADR050X001020183056NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H2025554615ml:10gCategory BXA06ADR050X001020183595NHSA
Chongqing Jian Neng Pharma Group Co., Ltd. romanized国药准字H2025337015ml:10gCategory BXA06ADR050X001020183692NHSA
Beijing Han Mei Bio Technology Co., Ltd. romanized国药准字H2025403515ml:10gCategory BXA06ADR050X001020184761NHSA
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254720200ml:133.4gCategory BXA06ADR050X001020184778NHSA
Hunan Ji Zheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255715200ml:133.4gCategory BXA06ADR050X001020184994NHSA
Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255382200ml:133.4gCategory BXA06ADR050X001020185010NHSA
Chengdu Ke Lai Meng Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025571915ml:10gCategory BXA06ADR050X001020185240NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H202582875ml:3.3gCategory BXA06ADR050X001030101122NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H2025829060ml:40.02gCategory BXA06ADR050X001030182209NHSA
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025334915ml:10gCategory BXA06ADR050X001030183056NHSA
Hunan Ji Zheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025571415ml:10gCategory BXA06ADR050X001030184994NHSA
Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025334915ml:10gCategory BXA06ADR050X001030283056NHSA
Mei Luo Pharma Co., Ltd. romanized国药准字H2025828615ml:10gCategory BXA06ADR050X001040101122NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20258291100ml:66.7gCategory BXA06ADR050X001040182209NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20253168200ml:133.4gCategory BXA06ADR050X001050180651NHSA
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7gCategory BXA06ADR050X001010100041NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010101123NHSA
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%Category BXA06ADR050X001010101150NHSA
Jian Min Pharma Group Co., Ltd. romanized国药准字H20244664200ml:133.4gCategory BXA06ADR050X001010101946NHSA
Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized国药准字H2010362160ml:40.02gCategory BXA06ADR050X001010102166NHSA
Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized国药准字H10890034100ml:50gCategory BXA06ADR050X001010102471NHSA
Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized国药准字H2024942315ml:10gCategory BXA06ADR050X001010102964NHSA
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized国药准字H2024955815ml:10gCategory BXA06ADR050X001010103804NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10gCategory BXA06ADR050X001010104043NHSA
Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanized国药准字H2007400910ml:5gCategory BXA06ADR050X001010104201NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H20234275200ml:133.4gCategory BXA06ADR050X001010104948NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20093523100ml:66.7gCategory BXA06ADR050X001010105006NHSA
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10gCategory BXA06ADR050X001010105031NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20249475200ml:133.4gCategory BXA06ADR050X001010105816NHSA
Fresenius Kabi Austria GmbHH20160470100ml:67gCategory BXA06ADR050X001010178433NHSA
Abbott B.V.国药准字HJ20171057667mg/mlCategory BXA06ADR050X001010178890NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010180528NHSA
Su Zhou Yi Fan Pharma Co., Ltd. romanized国药准字J20170046100ml: 67gCategory BXA06ADR050X001010180637NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10gCategory BXA06ADR050X001010180651NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001010181575NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)Category BXA06ADR050X001010182209NHSA
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10gCategory BXA06ADR050X001010182249NHSA
Bao Ding Ai Hui Pharma Co., Ltd. romanized国药准字H20249742200ml:133.4gCategory BXA06ADR050X001010182314NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10gCategory BXA06ADR050X001010183242NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H20243526100ml:66.7gCategory BXA06ADR050X001010183644NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H2024934215ml:10gCategory BXA06ADR050X001010183719NHSA
Jiangsu Yue Xing Pharma Co., Ltd. romanized国药准字H20249283200ml:133.4gCategory BXA06ADR050X001010183775NHSA
Hainan Mei Kang Da Pharma Co., Ltd. romanized国药准字H2024371315ml:10gCategory BXA06ADR050X001010183920NHSA
Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024979515ml:10gCategory BXA06ADR050X001010184196NHSA
Hua Run Jiang Zhong Pharma Co., Ltd. romanized国药准字H2024422715ml:10gCategory BXA06ADR050X001010184211NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024462315ml:10gCategory BXA06ADR050X001010184221NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H20244825200ml:133.4gCategory BXA06ADR050X001010184227NHSA
Hua Cui International Bio Technology (Guangdong) Co., Ltd. romanized国药准字H20249304100ml:66.7gCategory BXA06ADR050X001010184487NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001010184745NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010201123NHSA
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%Category BXA06ADR050X001010201150NHSA
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized国药准字H2024955815ml:10gCategory BXA06ADR050X001010203804NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10gCategory BXA06ADR050X001010204043NHSA
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10gCategory BXA06ADR050X001010205031NHSA
Yunnan Kang Jian Shan Mei Pharmaceutical Co., Ltd. romanized国药准字H53020078100ml:50gCategory BXA06ADR050X001010205681NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010280528NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10gCategory BXA06ADR050X001010280651NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001010281575NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)Category BXA06ADR050X001010282209NHSA
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10gCategory BXA06ADR050X001010282249NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10gCategory BXA06ADR050X001010283242NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H2024934215ml:10gCategory BXA06ADR050X001010283719NHSA
Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024979515ml:10gCategory BXA06ADR050X001010284196NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024462315ml:10gCategory BXA06ADR050X001010284221NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001010284745NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010301123NHSA
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%Category BXA06ADR050X001010301150NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10gCategory BXA06ADR050X001010304043NHSA
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10gCategory BXA06ADR050X001010305031NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010380528NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10gCategory BXA06ADR050X001010380651NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001010381575NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)Category BXA06ADR050X001010382209NHSA
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10gCategory BXA06ADR050X001010382249NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10gCategory BXA06ADR050X001010383242NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001010384745NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010401123NHSA
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%Category BXA06ADR050X001010401150NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10gCategory BXA06ADR050X001010404043NHSA
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10gCategory BXA06ADR050X001010405031NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010480528NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001010481575NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)Category BXA06ADR050X001010482209NHSA
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10gCategory BXA06ADR050X001010482249NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10gCategory BXA06ADR050X001010483242NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010501123NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10gCategory BXA06ADR050X001010504043NHSA
Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized国药准字H2024925015ml:10gCategory BXA06ADR050X001010505031NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010580528NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001010581575NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)Category BXA06ADR050X001010582209NHSA
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10gCategory BXA06ADR050X001010582249NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10gCategory BXA06ADR050X001010583242NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010601123NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H2024974915ml:10gCategory BXA06ADR050X001010604043NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010680528NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001010681575NHSA
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized国药准字H2024925315ml:10gCategory BXA06ADR050X001010682249NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H2024934715ml:10gCategory BXA06ADR050X001010683242NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001010701123NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001010780528NHSA
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7gCategory BXA06ADR050X001020100041NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H20093300100ml:50gCategory BXA06ADR050X001020101123NHSA
Dan Dong Kang Fu Pharmaceutical Co., Ltd. romanized国药准字H1089005750%Category BXA06ADR050X001020101150NHSA
Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized国药准字H2010362160ml:40.02gCategory BXA06ADR050X001020102166NHSA
Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized国药准字H10890034100ml:50gCategory BXA06ADR050X001020102471NHSA
Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H20249750100ml:66.7gCategory BXA06ADR050X001020104043NHSA
Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanized国药准字H20074010100ml:50gCategory BXA06ADR050X001020104201NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H20093524250ml:166.8gCategory BXA06ADR050X001020105006NHSA
Fresenius Kabi Austria GmbHH20160470100ml:67gCategory BXA06ADR050X001020178433NHSA
Abbott B.V.国药准字HJ20171057667mg/mlCategory BXA06ADR050X001020178890NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H20234274100ml:66.7gCategory BXA06ADR050X001020180528NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10gCategory BXA06ADR050X001020180651NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001020181575NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized国药准字H20233728667mg/ml(15ml:10g、200ml:133.4g)Category BXA06ADR050X001020182209NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H20249348200ml:133.4gCategory BXA06ADR050X001020183242NHSA
Hainan Mei Kang Da Pharma Co., Ltd. romanized国药准字H20243714100ml:66.7gCategory BXA06ADR050X001020183920NHSA
Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized国药准字H202497965ml:3.3gCategory BXA06ADR050X001020184196NHSA
Hua Run Jiang Zhong Pharma Co., Ltd. romanized国药准字H20244228200ml:133.4gCategory BXA06ADR050X001020184211NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244624200ml:133.4gCategory BXA06ADR050X001020184221NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001020184227NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001020184745NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001020281575NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001020284227NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001020284745NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001020384227NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001020384745NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001020484227NHSA
Beijing Fu Xin An Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H2024469015ml:10gCategory BXA06ADR050X001020484745NHSA
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7gCategory BXA06ADR050X001030100041NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001030101123NHSA
Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized国药准字H2010362160ml:40.02gCategory BXA06ADR050X001030102166NHSA
Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanized国药准字H2007400910ml:5gCategory BXA06ADR050X001030104201NHSA
Fresenius Kabi Austria GmbH国药准字HJ2017015215ml:10gCategory BXA06ADR050X001030178433NHSA
Abbott B.V.国药准字HJ20171057667mg/mlCategory BXA06ADR050X001030178890NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001030180528NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10gCategory BXA06ADR050X001030180651NHSA
Sichuan De Feng Pharma Co., Ltd. romanized国药准字H20223553667mg/mL(5ml:3.3g、15ml:10g、100ml:66.7g、200ml:133.4g)Category BXA06ADR050X001030181575NHSA
Hua Run Jiang Zhong Pharma Co., Ltd. romanized国药准字H2024422715ml:10gCategory BXA06ADR050X001030184211NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001030184227NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001030201123NHSA
Fresenius Kabi Austria GmbH国药准字HJ2017015215ml:10gCategory BXA06ADR050X001030278433NHSA
Abbott B.V.国药准字HJ20171057667mg/mlCategory BXA06ADR050X001030278890NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001030280528NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001030284227NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001030301123NHSA
Beijing Mai Kang Pharma Co., Ltd. romanized国药准字H2023427315ml:10gCategory BXA06ADR050X001030380528NHSA
Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized国药准字H2024482415ml:10gCategory BXA06ADR050X001030384227NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001030401123NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001030501123NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H2009329910ml:5gCategory BXA06ADR050X001030601123NHSA
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H20065730100ml:66.7gCategory BXA06ADR050X001040100041NHSA
Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized国药准字H20093300100ml:50gCategory BXA06ADR050X001040101123NHSA
Fresenius Kabi Austria GmbH国药准字HJ20170248100ml:67gCategory BXA06ADR050X001040178433NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H2024360115ml:10gCategory BXA06ADR050X001040180651NHSA
Fresenius Kabi Austria GmbH国药准字HJ20160470100ml:67gCategory BXA06ADR050X001050178433NHSA
Fresenius Kabi Austria GmbH国药准字HJ20160470100ml:67gCategory BXA06ADR050X001050278433NHSA
Fujian Sheng Rong Heng Pharmaceuticals Co., Ltd. romanized国药准字H2026445715ml:10gCategory BXA06ADR050X001020184977NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 34 filings and 23 distinct first applicants.

Generic 29 · Supplement 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized; Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanizedCYHS2600520Generic2026/02/25Not stated by sourceCDE
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS2602064Generic2026/08/20Not stated by sourceCDE
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS2602063Generic2026/08/20Not stated by sourceCDE
Jiangsu Yue Xing Pharma Co., Ltd. romanizedCYHB2501371Supplement2025/07/10Not stated by sourceCDE
Jiangsu Shen Hua Pharma Co., Ltd. romanizedCYHS2504208Generic2025/12/06Not stated by sourceCDE
Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanizedCYHS2504268Generic2025/12/12Not stated by sourceCDE
Hainan Si Da Pharmaceutical Co., Ltd. romanizedCYHB2601906Supplement2026/10/19Not stated by sourceCDE
Hainan Si Da Pharmaceutical Co., Ltd. romanizedCYHB2601905Supplement2026/10/19Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2602265Generic2026/09/10Not stated by sourceCDE
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS2602186Generic2026/09/02Not stated by sourceCDE
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS2602185Generic2026/09/02Not stated by sourceCDE
Zhejiang Guo Jing Pharma Co., Ltd. romanizedCYHS2601987Generic2026/08/13Not stated by sourceCDE
Jiangxi Shimei Pharmaceutical Co., LtdCYHS2601959Generic2026/08/10Not stated by sourceCDE
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS2601547Generic2026/07/01Not stated by sourceCDE
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS2601546Generic2026/07/01Not stated by sourceCDE
Hubei Mei Si Chuang Pharma Co., Ltd. romanizedCYHB2601115Supplement2026/06/12Not stated by sourceCDE
Hubei Mei Si Chuang Pharma Co., Ltd. romanizedCYHB2601108Supplement2026/06/12Not stated by sourceCDE
Henan Ling Rui Pharmaceutical Co., Ltd. romanizedCYHS2600646Generic2026/03/12Not stated by sourceCDE
Zhejiang Jin Li Yuan Pharma Co., Ltd. romanizedCYHS2600322Generic2026/01/31Not stated by sourceCDE
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS2504252Generic2025/12/11Not stated by sourceCDE
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS2504251Generic2025/12/11Not stated by sourceCDE
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanizedCYHS2504250Generic2025/12/11Not stated by sourceCDE
Jiangxi Yao Dou Ren He Pharmaceutical Co., Ltd. romanizedCYHS2503984Generic2025/11/18Not stated by sourceCDE
Tianjin He Zhi Pharma Group Co., Ltd. romanizedCYHS2503347Generic2025/09/10Not stated by sourceCDE
Tianjin He Zhi Pharma Group Co., Ltd. romanizedCYHS2503346Generic2025/09/10Not stated by sourceCDE
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedCYHS2502985Generic2025/08/15Not stated by sourceCDE
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedCYHS2502984Generic2025/08/15Not stated by sourceCDE
Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanizedCYHS2502982Generic2025/08/15Not stated by sourceCDE
Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCYHS2502896Generic2025/08/09Not stated by sourceCDE
Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCYHS2502895Generic2025/08/09Not stated by sourceCDE
Wuhan An Cheng Pharmaceuticals Co., Ltd. romanized; Hubei Ji An Tang Pharma Co., Ltd. romanizedCYHS2501838Generic2025/05/22Not stated by sourceCDE
Beijing Jin Dian Han Fang Pharma Co., Ltd. romanizedCYHS2501558Generic2025/04/25Not stated by sourceCDE
Henan Tai Feng Bio Technology Co., Ltd. romanizedCYHS2501451Generic2025/04/16Not stated by sourceCDE
Hubei Wu Shi Pharma Co., Ltd. romanizedCYHS2501168Generic2025/03/25Not stated by sourceCDE
New generic filings in 2026

Loaded records: 12 filings and 9 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized; Lai Yang Shi Jiang Bo Pharmaceutical Co., Ltd. romanizedCYHS2600520Generic2026/02/25Not stated by sourceCDE
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS2602064Generic2026/08/20Not stated by sourceCDE
Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanizedCYHS2602063Generic2026/08/20Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2602265Generic2026/09/10Not stated by sourceCDE
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS2602186Generic2026/09/02Not stated by sourceCDE
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS2602185Generic2026/09/02Not stated by sourceCDE
Zhejiang Guo Jing Pharma Co., Ltd. romanizedCYHS2601987Generic2026/08/13Not stated by sourceCDE
Jiangxi Shimei Pharmaceutical Co., LtdCYHS2601959Generic2026/08/10Not stated by sourceCDE
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS2601547Generic2026/07/01Not stated by sourceCDE
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanizedCYHS2601546Generic2026/07/01Not stated by sourceCDE
Henan Ling Rui Pharmaceutical Co., Ltd. romanizedCYHS2600646Generic2026/03/12Not stated by sourceCDE
Zhejiang Jin Li Yuan Pharma Co., Ltd. romanizedCYHS2600322Generic2026/01/31Not stated by sourceCDE
API registrations

Non-component matches: 1 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
乳果糖 · No verified English nameFresenius Kabi Austria GmbHY20170001096AExact ingredient2025/10/15CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/11/11No longer listed under review

    Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized

    CYHB2601564

    Fact date: 2026/11/11 · Site observation date: 2026/11/11

    Accepted: 2026/08/17

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/10 (approval no.: —; approval date: 2026/11/09); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 20

    NMPA · Table row 20 ↗ View source ↗
  2. 2026/11/11No longer listed under review

    Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

    CYHB2600092

    Fact date: 2026/11/11 · Site observation date: 2026/11/11

    Accepted: 2026/01/17

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/10 (approval no.: —; approval date: 2026/11/09); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 10

    NMPA · Table row 10 ↗ View source ↗
  3. 2026/11/09Supplement delivery

    Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized

    CYHB2601564

    Fact date: 2026/11/09 · Publication date: 2026/11/10 · Site observation date: 2026/11/10

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 20 ↗
  4. 2026/11/09Supplement delivery

    Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

    CYHB2600092

    Fact date: 2026/11/09 · Publication date: 2026/11/10 · Site observation date: 2026/11/10

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 10 ↗
  5. 2026/11/07No longer listed under review

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601876

    Fact date: 2026/11/07 · Site observation date: 2026/11/07

    Accepted: 2026/10/13

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/05); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 34

    NMPA · Table row 34 ↗ View source ↗
  6. 2026/11/07No longer listed under review

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601875

    Fact date: 2026/11/07 · Site observation date: 2026/11/07

    Accepted: 2026/10/13

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/05); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 33

    NMPA · Table row 33 ↗ View source ↗
  7. 2026/11/07No longer listed under review

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601874

    Fact date: 2026/11/07 · Site observation date: 2026/11/07

    Accepted: 2026/10/13

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/05); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 32

    NMPA · Table row 32 ↗ View source ↗
  8. 2026/11/07No longer listed under review

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601873

    Fact date: 2026/11/07 · Site observation date: 2026/11/07

    Accepted: 2026/10/13

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/05); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 31

    NMPA · Table row 31 ↗ View source ↗
  9. 2026/11/05Supplement delivery

    Ya Bang Pharmaceuticals Co., Ltd. romanized

    CYHB2601876

    Fact date: 2026/11/05 · Publication date: 2026/11/06 · Site observation date: 2026/11/06

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 34 ↗
  10. 2026/11/05Supplement delivery

    Ya Bang Pharmaceuticals Co., Ltd. romanized

    CYHB2601875

    Fact date: 2026/11/05 · Publication date: 2026/11/06 · Site observation date: 2026/11/06

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 33 ↗
  11. 2026/11/05Supplement delivery

    Ya Bang Pharmaceuticals Co., Ltd. romanized

    CYHB2601874

    Fact date: 2026/11/05 · Publication date: 2026/11/06 · Site observation date: 2026/11/06

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 32 ↗
  12. 2026/11/05Supplement delivery

    Ya Bang Pharmaceuticals Co., Ltd. romanized

    CYHB2601873

    Fact date: 2026/11/05 · Publication date: 2026/11/06 · Site observation date: 2026/11/06

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 31 ↗
  13. 2026/10/19Accepted

    Hainan Si Da Pharmaceutical Co., Ltd. romanized

    CYHB2601906

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  14. 2026/10/19Accepted

    Hainan Si Da Pharmaceutical Co., Ltd. romanized

    CYHB2601905

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  15. 2026/10/13Accepted

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601876

    Fact date: 2026/10/13 · Site observation date: 2026/10/22

    View source ↗
  16. 2026/10/13Accepted

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601875

    Fact date: 2026/10/13 · Site observation date: 2026/10/22

    View source ↗
  17. 2026/10/13Accepted

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601874

    Fact date: 2026/10/13 · Site observation date: 2026/10/22

    View source ↗
  18. 2026/10/13Accepted

    Ya Bang Pharmaceuticals Co., Ltd. romanized; Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized

    CYHB2601873

    Fact date: 2026/10/13 · Site observation date: 2026/10/22

    View source ↗
  19. 2026/09/17Accepted

    Lian Huan Pharma (An Qing) Co., Ltd. romanized; Jiangsu Lianhuan Pharmaceutical Co.,Ltd.

    CYHB2601757

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    View source ↗
  20. 2026/09/17Accepted

    Lian Huan Pharma (An Qing) Co., Ltd. romanized; Jiangsu Lianhuan Pharmaceutical Co.,Ltd.

    CYHB2601756

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    View source ↗
  21. 2026/09/10Accepted

    Chengdu Pusch Pharmaceutical Co., Ltd.

    CYHS2602265

    Fact date: 2026/09/10 · Site observation date: 2026/10/22

    View source ↗
  22. 2026/09/02Accepted

    Hebei Hua Chen Pharma Group Co., Ltd. romanized

    CYHS2602186

    Fact date: 2026/09/02 · Site observation date: 2026/10/22

    View source ↗
  23. 2026/09/02Accepted

    Hebei Hua Chen Pharma Group Co., Ltd. romanized

    CYHS2602185

    Fact date: 2026/09/02 · Site observation date: 2026/10/22

    View source ↗
  24. 2026/08/20Accepted
  25. 2026/08/20Accepted
  26. 2026/08/17Accepted

    Jiangxi Dan Kang Pharmaceutical Co., Ltd. romanized

    CYHB2601564

    Fact date: 2026/08/17 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.

NMPA drug delivery notices
Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete

First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.

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.

Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

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