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Public drug landscapesDrug landscape

Escitalopram Oxalate Tablets

As of 13 November 2026, for Escitalopram Oxalate Tablets, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 18 holders.

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

Listed in the US FDA Orange Book as LEXAPRO (NDA 021323, ABBVIE INC).

Last 90 days: Accepted: 4 applications

Current coverage may be incomplete

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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: Tablets. 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
LEXAPRO ABBVIE INC NDA 021323 · Product no. 001, 002, 003 TABLET ORAL HUMAN PRESCRIPTION DRUG 2002/08/14

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
ESCITALOPRAM ALMATICA PHARMA LLC NDA 219130 · Product no. 001 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 2025/08/29
LEXAPRO ABBVIE INC NDA 021365 · Product no. 001 SOLUTION ORAL DISCONTINUED 2002/11/27

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: 18 holders; 5 in the quality-and-efficacy consistency-evaluation category, and 12 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Shenyang Hua Tai Drug Research Co., Ltd. romanizedShenyang Fu Ning Pharma Co., Ltd. romanized国药准字H202647512026/06/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanizedAnhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized国药准字H202445172024/07/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanizedAnhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized国药准字H202445182024/07/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDXin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized国药准字H202436822024/05/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Kang Hong Pharma Group Co., Ltd. romanizedChengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H202345932023/12/05See sourceNot stated by sourceCDE
Chengdu Kang Hong Pharma Group Co., Ltd. romanizedChengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H202345922023/12/05See sourceGeneric approved under the new chemical-drug registration classificationCDE
Tian Di Heng Yi Pharmaceutical Co., Ltd. romanizedTian Di Heng Yi Pharmaceutical Co., Ltd. romanized国药准字H202340632023/08/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Tian Di Heng Yi Pharmaceutical Co., Ltd. romanizedTian Di Heng Yi Pharmaceutical Co., Ltd. romanized国药准字H202340622023/08/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanizedZhejiang Jiang Bei Pharma Co., Ltd. romanized国药准字H202332602023/03/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanizedZhejiang Jiang Bei Pharma Co., Ltd. romanized国药准字H202332612023/03/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Rui Yang Pharmaceutical Co., Ltd. romanizedRui Yang Pharmaceutical Co., Ltd. romanized国药准字H202236092022/08/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Rui Yang Pharmaceutical Co., Ltd. romanizedRui Yang Pharmaceutical Co., Ltd. romanized国药准字H202236072022/08/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Rui Yang Pharmaceutical Co., Ltd. romanizedRui Yang Pharmaceutical Co., Ltd. romanized国药准字H202236082022/08/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Lek Pharmaceuticals d.d.Sandoz Private Limited国药准字HJ202200032022/01/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hua Yuan Pharma Co., Ltd. romanizedHua Yuan Pharma Co., Ltd. romanized国药准字H202134742021/06/16See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hua Yuan Pharma Co., Ltd. romanizedHua Yuan Pharma Co., Ltd. romanized国药准字H202134752021/06/16See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hua Yuan Pharma Co., Ltd. romanizedHua Yuan Pharma Co., Ltd. romanized国药准字H202134732021/06/16See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanizedZhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized国药准字H201301052021/04/205mgDrug that passed quality-and-efficacy consistency evaluationCDE
Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanizedZhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized国药准字H201301062021/04/2010mgDrug that passed quality-and-efficacy consistency evaluationCDE
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanizedGuangdong Dong Yang Guang Pharma Co., Ltd. romanized国药准字H202132592021/04/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanizedGuangdong Dong Yang Guang Pharma Co., Ltd. romanized国药准字H202132602021/04/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanizedGuangdong Dong Yang Guang Pharma Co., Ltd. romanized国药准字H202132582021/04/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanizedGuangdong Dong Yang Guang Pharma Co., Ltd. romanized国药准字H202132572021/04/07See sourceGeneric approved under the new chemical-drug registration classificationCDE
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanizedFu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H202131932021/03/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanizedJilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H201401082020/09/25See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Sichuan Kelun Pharmaceutical Co., Ltd.Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H201841422020/09/04See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedJilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H201401092020/01/20See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H201933082019/11/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H201933002019/11/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Name not romanizedJewim Pharmaceutical (Shandong) Co., Ltd.国药准字H201033272018/09/26See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedJewim Pharmaceutical (Shandong) Co., Ltd.国药准字H200805992018/09/26See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedJewim Pharmaceutical (Shandong) Co., Ltd.国药准字H201035482018/09/26See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedHunan Dong Ting Pharma Co., Ltd. romanized国药准字H201433912018/05/14See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H200807882018/02/0710mgDrug that passed quality-and-efficacy consistency evaluationCDE
H. Lundbeck A/SH.Lundbeck A/SH201401212009/04/1620mgImported originator drugCDE
H. Lundbeck A/SH.Lundbeck A/SH201501612005/08/315mgImported originator drugCDE
H. Lundbeck A/SH.Lundbeck A/SH201501632005/08/3110mgImported 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: 35 distinct approval numbers and 20 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234592See sourceCategory AXN06ABA225A001010102016NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20184142See sourceCategory AXN06ABA225A001010102180NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20080788See sourceCategory AXN06ABA225A001010102292NHSA
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H20140109See sourceCategory AXN06ABA225A001010103454NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001010104111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223607See sourceCategory AXN06ABA225A001010104152NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H20243682See sourceCategory AXN06ABA225A001010104187NHSA
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized国药准字H20213193See sourceCategory AXN06ABA225A001010104561NHSA
Zhejiang Hua Yuan Pharma Co., Ltd. romanized国药准字H20213473See sourceCategory AXN06ABA225A001010104646NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193308See sourceCategory AXN06ABA225A001010104647NHSA
Zhejiang Hai Sen Pharma Co., Ltd. romanized国药准字H2013010610mgCategory AXN06ABA225A001010104656NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H20143391See sourceCategory AXN06ABA225A001010104917NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20213257See sourceCategory AXN06ABA225A001010106988NHSA
H. Lundbeck A/S国药准字HJ20150163See sourceCategory AXN06ABA225A001010178996NHSA
Lek Pharmaceuticals d.d.国药准字HJ20220003See sourceCategory AXN06ABA225A001010179428NHSA
Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized国药准字H20234062See sourceCategory AXN06ABA225A001010180086NHSA
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H20244517See sourceCategory AXN06ABA225A001010181400NHSA
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized国药准字H20233260See sourceCategory AXN06ABA225A001010183254NHSA
Shenyang Hua Tai Drug Research Co., Ltd. romanized国药准字H20264751See sourceCategory AXN06ABA225A001010183285NHSA
Shandong Pu Rui Man Pharma Co., Ltd. romanized国药准字H20263660See sourceCategory AXN06ABA225A001010184621NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234592See sourceCategory AXN06ABA225A001010202016NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20184142See sourceCategory AXN06ABA225A001010202180NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20080788See sourceCategory AXN06ABA225A001010202292NHSA
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H20140109See sourceCategory AXN06ABA225A001010203454NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001010204111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223607See sourceCategory AXN06ABA225A001010204152NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H20243682See sourceCategory AXN06ABA225A001010204187NHSA
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized国药准字H20213193See sourceCategory AXN06ABA225A001010204561NHSA
Zhejiang Hua Yuan Pharma Co., Ltd. romanized国药准字H20213473See sourceCategory AXN06ABA225A001010204646NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193308See sourceCategory AXN06ABA225A001010204647NHSA
Zhejiang Hai Sen Pharma Co., Ltd. romanized国药准字H2013010610mgCategory AXN06ABA225A001010204656NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H20143391See sourceCategory AXN06ABA225A001010204917NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20213257See sourceCategory AXN06ABA225A001010206988NHSA
H. Lundbeck A/S国药准字HJ20150163See sourceCategory AXN06ABA225A001010278996NHSA
Lek Pharmaceuticals d.d.国药准字HJ20220003See sourceCategory AXN06ABA225A001010279428NHSA
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized国药准字H20233260See sourceCategory AXN06ABA225A001010283254NHSA
Shandong Pu Rui Man Pharma Co., Ltd. romanized国药准字H20263660See sourceCategory AXN06ABA225A001010284621NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234592See sourceCategory AXN06ABA225A001010302016NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20184142See sourceCategory AXN06ABA225A001010302180NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20080788See sourceCategory AXN06ABA225A001010302292NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001010304111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223607See sourceCategory AXN06ABA225A001010304152NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H20243682See sourceCategory AXN06ABA225A001010304187NHSA
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized国药准字H20213193See sourceCategory AXN06ABA225A001010304561NHSA
Zhejiang Hua Yuan Pharma Co., Ltd. romanized国药准字H20213473See sourceCategory AXN06ABA225A001010304646NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193308See sourceCategory AXN06ABA225A001010304647NHSA
Zhejiang Hai Sen Pharma Co., Ltd. romanized国药准字H2013010610mgCategory AXN06ABA225A001010304656NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H20143391See sourceCategory AXN06ABA225A001010304917NHSA
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized国药准字H20233260See sourceCategory AXN06ABA225A001010383254NHSA
Shandong Pu Rui Man Pharma Co., Ltd. romanized国药准字H20263660See sourceCategory AXN06ABA225A001010384621NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234592See sourceCategory AXN06ABA225A001010402016NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20184142See sourceCategory AXN06ABA225A001010402180NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20080788See sourceCategory AXN06ABA225A001010402292NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001010404111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223607See sourceCategory AXN06ABA225A001010404152NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193308See sourceCategory AXN06ABA225A001010404647NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H20143391See sourceCategory AXN06ABA225A001010404917NHSA
Shandong Pu Rui Man Pharma Co., Ltd. romanized国药准字H20263660See sourceCategory AXN06ABA225A001010484621NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001010504111NHSA
Shandong Pu Rui Man Pharma Co., Ltd. romanized国药准字H20263660See sourceCategory AXN06ABA225A001010584621NHSA
Shandong Pu Rui Man Pharma Co., Ltd. romanized国药准字H20263660See sourceCategory AXN06ABA225A001010684621NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234593See sourceCategory AXN06ABA225A001020102016NHSA
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H20140108See sourceCategory AXN06ABA225A001020103454NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103548See sourceCategory AXN06ABA225A001020104111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223608See sourceCategory AXN06ABA225A001020104152NHSA
Zhejiang Hua Yuan Pharma Co., Ltd. romanized国药准字H20213474See sourceCategory AXN06ABA225A001020104646NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193300See sourceCategory AXN06ABA225A001020104647NHSA
Zhejiang Hai Sen Pharma Co., Ltd. romanized国药准字H201301055mgCategory AXN06ABA225A001020104656NHSA
Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized国药准字H20213258See sourceCategory AXN06ABA225A001020106988NHSA
H.Lundbeck A/SH20150161See sourceCategory AXN06ABA225A001020178996NHSA
Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized国药准字H20234063See sourceCategory AXN06ABA225A001020180086NHSA
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H20244518See sourceCategory AXN06ABA225A001020181400NHSA
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized国药准字H20233261See sourceCategory AXN06ABA225A001020183254NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234593See sourceCategory AXN06ABA225A001020202016NHSA
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H20140108See sourceCategory AXN06ABA225A001020203454NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103548See sourceCategory AXN06ABA225A001020204111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223608See sourceCategory AXN06ABA225A001020204152NHSA
Zhejiang Hua Yuan Pharma Co., Ltd. romanized国药准字H20213474See sourceCategory AXN06ABA225A001020204646NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193300See sourceCategory AXN06ABA225A001020204647NHSA
Zhejiang Hai Sen Pharma Co., Ltd. romanized国药准字H201301055mgCategory AXN06ABA225A001020204656NHSA
H.Lundbeck A/SH20150161See sourceCategory AXN06ABA225A001020278996NHSA
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized国药准字H20233261See sourceCategory AXN06ABA225A001020283254NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234593See sourceCategory AXN06ABA225A001020302016NHSA
Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized国药准字H20140108See sourceCategory AXN06ABA225A001020303454NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103548See sourceCategory AXN06ABA225A001020304111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223608See sourceCategory AXN06ABA225A001020304152NHSA
Zhejiang Hua Yuan Pharma Co., Ltd. romanized国药准字H20213474See sourceCategory AXN06ABA225A001020304646NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20193300See sourceCategory AXN06ABA225A001020304647NHSA
Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized国药准字H20233261See sourceCategory AXN06ABA225A001020383254NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20234593See sourceCategory AXN06ABA225A001020402016NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223608See sourceCategory AXN06ABA225A001020404152NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030104111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223609See sourceCategory AXN06ABA225A001030104152NHSA
Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20213475See sourceCategory AXN06ABA225A001030104646NHSA
Zhejiang Hai Sen Pharma Co., Ltd. romanized国药准字H2013010610mgCategory AXN06ABA225A001030104656NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030204111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223609See sourceCategory AXN06ABA225A001030204152NHSA
Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20213475See sourceCategory AXN06ABA225A001030204646NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030304111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223609See sourceCategory AXN06ABA225A001030304152NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030404111NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20223609See sourceCategory AXN06ABA225A001030404152NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030504111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030604111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001030704111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001040104111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001050104111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001050204111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103327See sourceCategory AXN06ABA225A001050304111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103548See sourceCategory AXN06ABA225A001060104111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20103548See sourceCategory AXN06ABA225A001060204111NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20080599See sourceCategory AXN06ABA225A001070104111NHSA

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: 6 filings and 3 distinct first applicants.

Generic 4 · Import 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shanghai Shyndec Pharmaceutical Co., Ltd.CYHS2602144Generic2026/08/27Not stated by sourceCDE
Shanghai Shyndec Pharmaceutical Co., Ltd.CYHS2602143Generic2026/08/27Not stated by sourceCDE
Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2602037Generic2026/08/18Not stated by sourceCDE
Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2602036Generic2026/08/18Not stated by sourceCDE
Maxmind Pharmaceutical S.L.; Macleods Pharmaceuticals Ltd.; Maxmind Biotechnology (Hainan) Co. Ltd.JYHS2400060Import2024/12/05Not stated by sourceCDE
Maxmind Pharmaceutical S.L.; Macleods Pharmaceuticals Ltd.; Maxmind Biotechnology (Hainan) Co. Ltd.JYHS2400059Import2024/12/05Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shanghai Shyndec Pharmaceutical Co., Ltd.CYHS2602144Generic2026/08/27Not stated by sourceCDE
Shanghai Shyndec Pharmaceutical Co., Ltd.CYHS2602143Generic2026/08/27Not stated by sourceCDE
Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2602037Generic2026/08/18Not stated by sourceCDE
Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2602036Generic2026/08/18Not stated by sourceCDE
API registrations

Non-component matches: 16 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
草酸艾司西酞普兰 · No verified English nameShanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanizedY20260000777IExact ingredient2026/09/10CDE
草酸艾司西酞普兰 · No verified English nameHubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY20260000275IExact ingredient2026/04/29CDE
草酸艾司西酞普兰 · No verified English nameVirupaksha Organics LimitedY20240000675AExact ingredient2026/04/21CDE
草酸艾司西酞普兰 · No verified English nameHetero Labs LimitedY20210001164AExact ingredient2024/12/29CDE
草酸艾司西酞普兰 · No verified English nameWan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanizedY20200000363IExact ingredient2020/05/15CDE
草酸艾司西酞普兰 · No verified English nameOlon S.p.A.Y20190021297AExact ingredient2022/10/27CDE
草酸艾司西酞普兰 · No verified English nameShandong Rui Shun Pharma Co., Ltd. romanizedY20190009855AExact ingredient2024/01/17CDE
草酸艾司西酞普兰 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20190009839AExact ingredient2026/05/20CDE
草酸艾司西酞普兰 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20190008922AExact ingredient2024/07/26CDE
草酸艾司西酞普兰 · No verified English nameShandong An Xin Pharmaceutical Co., Ltd. romanizedY20190008896AExact ingredient2024/04/30CDE
草酸艾司西酞普兰 · No verified English nameZhejiang Hai Sen Pharma Co., Ltd. romanizedY20190007282AExact ingredient2023/08/16CDE
草酸艾司西酞普兰 · No verified English nameWuxi Ji Da Pharmaceutical Co., Ltd. romanizedY20190006965AExact ingredient2023/03/24CDE
草酸艾司西酞普兰 · No verified English nameHunan Dong Ting Pharma Co., Ltd. romanizedY20190001441AExact ingredient2024/10/18CDE
草酸艾司西酞普兰 · No verified English nameJilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanizedY20190001382AExact ingredient2025/08/09CDE
草酸艾司西酞普兰 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20180001104AExact ingredient2026/05/20CDE
草酸艾司西酞普兰 · No verified English nameShandong Rui Shun Pharma Co., Ltd. romanizedY20170001891AExact ingredient2024/09/26CDE
草酸艾司西酞普兰 · No verified English nameSHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDY20170001449AExact ingredient2024/02/08CDE
草酸艾司西酞普兰 · No verified English nameShanghai Shyndec Pharmaceutical Co., Ltd.Y20170001293AExact ingredient2024/01/18CDE
草酸艾司西酞普兰 · No verified English nameRui Yang Pharmaceutical Co., Ltd. romanizedY20170001283AExact ingredient2025/01/03CDE
草酸艾司西酞普兰 · No verified English nameRu Yuan Dong Yang Guang Pharma Co., Ltd. romanizedY20170000762AExact ingredient2023/08/10CDE
草酸艾司西酞普兰 · No verified English nameWan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanizedY20170000654AExact ingredient2023/03/24CDE
草酸艾司西酞普兰 · No verified English nameCISEN PHARMACEUTICAL CO., LTD.Y20170000637IExact ingredient—CDE

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. 2026/08/27Accepted

    Shanghai Shyndec Pharmaceutical Co., Ltd.

    CYHS2602144

    Fact date: 2026/08/27 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/08/27Accepted

    Shanghai Shyndec Pharmaceutical Co., Ltd.

    CYHS2602143

    Fact date: 2026/08/27 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/08/18Accepted

    Wuhan Ren Fu Pharma Co., Ltd. romanized

    CYHS2602037

    Fact date: 2026/08/18 · Site observation date: 2026/10/22

    View source ↗
  4. 2026/08/18Accepted

    Wuhan Ren Fu Pharma Co., Ltd. romanized

    CYHS2602036

    Fact date: 2026/08/18 · 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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