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Public drug landscapesDrug landscape

Vortioxetine Hydrobromide Tablets

As of 13 November 2026, for Vortioxetine Hydrobromide Tablets, 10 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 27 holders.

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

Listed in the US FDA Orange Book as TRINTELLIX (NDA 204447, TAKEDA PHARMACEUTICALS USA INC).

Last 90 days: Accepted: 5 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 1 of 1 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
TRINTELLIX TAKEDA PHARMACEUTICALS USA INC NDA 204447 · Product no. 001, 002, 004 TABLET ORAL HUMAN PRESCRIPTION DRUG 2013/09/30
TRINTELLIX TAKEDA PHARMACEUTICALS USA INC NDA 204447 · Product no. 003 TABLET ORAL DISCONTINUED 2013/09/30

Other dosage forms of the same ingredient

No listings in this group among the displayed brand names.

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: 27 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 26 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanizedHua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized国药准字H202647472026/06/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jilin Si Huan Pharmaceutical Co., Ltd. romanizedJilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H202646242026/06/03See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanizedJiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized国药准字H202635322026/03/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanizedJiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized国药准字H202635332026/03/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanizedShandong Yu Xin Pharma Co., Ltd. romanized国药准字H202563462025/12/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanizedChengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202562612025/12/16See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hefei Innovation Pharmaceuticals Technology Co., Ltd. romanizedAnhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized国药准字H202559432025/11/12See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hefei Innovation Pharmaceuticals Technology Co., Ltd. romanizedAnhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized国药准字H202559422025/11/1210mgGeneric approved under the new chemical-drug registration classificationCDE
YaoPharma Co., Ltd.YaoPharma Co., Ltd.国药准字H202556012025/09/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanizedLe Pu Pharmaceutical Technology Co., Ltd. romanized国药准字H202551952025/08/26See sourceGeneric approved under the new chemical-drug registration classificationCDE
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanizedLe Pu Pharmaceutical Technology Co., Ltd. romanized国药准字H202551942025/08/26See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hunan Sheng Xiang Zhong Pharmaceutical Co., Ltd. romanizedHunan Sheng Xiang Zhong Pharmaceutical Co., Ltd. romanized国药准字H202543492025/05/27See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedShijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized国药准字H202531492025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202531902025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202531612025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu En Hua Pharma Co., Ltd. romanizedJiangsu En Hua Pharma Co., Ltd. romanized国药准字H202531532025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202531912025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou He Kang Pharma Co., Ltd. romanizedHangzhou He Kang Pharma Co., Ltd. romanized国药准字H202495942024/12/01See sourceGeneric approved under the new chemical-drug registration classificationCDE
Bei Da Pharmaceuticals Co., Ltd. romanizedBei Da Pharmaceuticals Co., Ltd. romanized国药准字H202493562024/11/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Bei Da Pharmaceuticals Co., Ltd. romanizedBei Da Pharmaceuticals Co., Ltd. romanized国药准字H202493582024/11/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Bei Da Pharmaceuticals Co., Ltd. romanizedBei Da Pharmaceuticals Co., Ltd. romanized国药准字H202493572024/11/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanizedFujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized国药准字H202443422024/06/28See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jewim Pharmaceutical (Shandong) Co., Ltd.Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202438912024/06/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized国药准字H202431472024/02/06See sourceGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized国药准字H202431482024/02/06See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202430272024/01/09See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hebei Long Hai Pharma Co., Ltd. romanizedHebei Long Hai Pharma Co., Ltd. romanized国药准字H202334172023/04/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yangtze River Pharmaceutical Group Co., LtdYangtze River Pharmaceutical Group Co., Ltd国药准字H202331552023/02/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanizedYi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized国药准字H202233412022/05/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Hao Sen Pharma Group Co., Ltd. romanizedJiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H202232822022/05/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Hao Sen Pharma Group Co., Ltd. romanizedJiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H202233032022/05/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
CSPC OUYI PHARMACEUTICAL CO., LTD.CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H202232372022/04/19See 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H202138442021/11/03See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Brilliant Pharmaceutical Co., Ltd.Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202138232021/10/26See sourceGeneric approved under the new chemical-drug registration classificationCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H202135972021/07/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H202135982021/07/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
H.Lundbeck A/SH.Lundbeck A/SH20170381;H201703822017/11/21See sourceImported originator drugCDE
H.Lundbeck A/SH.Lundbeck A/SH20170383;H201703842017/11/21See sourceImported originator drugCDE
CSPC OUYI PHARMACEUTICAL CO., LTD.CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H202234362022/06/28See sourceGeneric approved under the new chemical-drug registration classificationCDE

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 23 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jiangsu En Hua Pharma Co., Ltd. romanized国药准字H20253153See sourceNot stated by sourceXN06AXF704A001010101435NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223303See sourceNot stated by sourceXN06AXF704A001010101444NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213597See sourceNot stated by sourceXN06AXF704A001010101523NHSA
Yangtze River Pharmaceutical Group Co., Ltd国药准字H20233155See sourceNot stated by sourceXN06AXF704A001010101749NHSA
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H20213823See sourceNot stated by sourceXN06AXF704A001010102013NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20213844See sourceNot stated by sourceXN06AXF704A001010102016NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20243027See sourceNot stated by sourceXN06AXF704A001010102763NHSA
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H20233417See sourceNot stated by sourceXN06AXF704A001010102766NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20223436See sourceNot stated by sourceXN06AXF704A001010102770NHSA
Jilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H20264624See sourceNot stated by sourceXN06AXF704A001010103492NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20243891See sourceNot stated by sourceXN06AXF704A001010104111NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243147See sourceNot stated by sourceXN06AXF704A001010104127NHSA
Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized国药准字H20244342See sourceNot stated by sourceXN06AXF704A001010104799NHSA
Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized国药准字H20254349See sourceNot stated by sourceXN06AXF704A001010104971NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H20249356See sourceNot stated by sourceXN06AXF704A001010109586NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20253190See sourceNot stated by sourceXN06AXF704A001010109920NHSA
H. Lundbeck A/S国药准字HJ20170383See sourceNot stated by sourceXN06AXF704A001010178996NHSA
Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized国药准字H20253149See sourceNot stated by sourceXN06AXF704A001010179261NHSA
Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized国药准字H20223341See sourceNot stated by sourceXN06AXF704A001010181048NHSA
Hangzhou He Kang Pharma Co., Ltd. romanized国药准字H20249594See sourceNot stated by sourceXN06AXF704A001010181760NHSA
Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized国药准字H20256346See sourceNot stated by sourceXN06AXF704A001010183363NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H20255194See sourceNot stated by sourceXN06AXF704A001010184207NHSA
Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H20256261See sourceNot stated by sourceXN06AXF704A001010185151NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223303See sourceNot stated by sourceXN06AXF704A001010201444NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213597See sourceNot stated by sourceXN06AXF704A001010201523NHSA
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H20233417See sourceNot stated by sourceXN06AXF704A001010202766NHSA
Jilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H20264624See sourceNot stated by sourceXN06AXF704A001010203492NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20243891See sourceNot stated by sourceXN06AXF704A001010204111NHSA
H. Lundbeck A/S国药准字HJ20170383See sourceNot stated by sourceXN06AXF704A001010278996NHSA
Hangzhou He Kang Pharma Co., Ltd. romanized国药准字H20249594See sourceNot stated by sourceXN06AXF704A001010281760NHSA
Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized国药准字H20256346See sourceNot stated by sourceXN06AXF704A001010283363NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H20255194See sourceNot stated by sourceXN06AXF704A001010284207NHSA
Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized国药准字H20256261See sourceNot stated by sourceXN06AXF704A001010285151NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223303See sourceNot stated by sourceXN06AXF704A001010301444NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213597See sourceNot stated by sourceXN06AXF704A001010301523NHSA
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H20233417See sourceNot stated by sourceXN06AXF704A001010302766NHSA
Jilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H20264624See sourceNot stated by sourceXN06AXF704A001010303492NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H20243891See sourceNot stated by sourceXN06AXF704A001010304111NHSA
H.Lundbeck A/SH20170384See sourceNot stated by sourceXN06AXF704A001010378996NHSA
Hangzhou He Kang Pharma Co., Ltd. romanized国药准字H20249594See sourceNot stated by sourceXN06AXF704A001010381760NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223303See sourceNot stated by sourceXN06AXF704A001010401444NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213597See sourceNot stated by sourceXN06AXF704A001010401523NHSA
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H20233417See sourceNot stated by sourceXN06AXF704A001010402766NHSA
H.Lundbeck A/SH20170384See sourceNot stated by sourceXN06AXF704A001010478996NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223282See sourceNot stated by sourceXN06AXF704A001020101444NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213598See sourceNot stated by sourceXN06AXF704A001020101523NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20213844See sourceNot stated by sourceXN06AXF704A001020102016NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20223237See sourceNot stated by sourceXN06AXF704A001020102770NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243148See sourceNot stated by sourceXN06AXF704A001020104127NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H20249357See sourceNot stated by sourceXN06AXF704A001020109586NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20253191See sourceNot stated by sourceXN06AXF704A001020109920NHSA
H.Lundbeck A/SH20170381See sourceNot stated by sourceXN06AXF704A001020178996NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H20255195See sourceNot stated by sourceXN06AXF704A001020184207NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223282See sourceNot stated by sourceXN06AXF704A001020201444NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213598See sourceNot stated by sourceXN06AXF704A001020201523NHSA
Chengdu Kang Hong Pharma Group Co., Ltd. romanized国药准字H20213844See sourceNot stated by sourceXN06AXF704A001020202016NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H20253191See sourceNot stated by sourceXN06AXF704A001020209920NHSA
H.Lundbeck A/SH20170381See sourceNot stated by sourceXN06AXF704A001020278996NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H20255195See sourceNot stated by sourceXN06AXF704A001020284207NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213598See sourceNot stated by sourceXN06AXF704A001020301523NHSA
H.Lundbeck A/SH20170382See sourceNot stated by sourceXN06AXF704A001020378996NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H20213598See sourceNot stated by sourceXN06AXF704A001020401523NHSA
H.Lundbeck A/SH20170382See sourceNot stated by sourceXN06AXF704A001020478996NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20237133See sourceNot stated by sourceXN06AXF704A001030101444NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H20249358See sourceNot stated by sourceXN06AXF704A001030109586NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20237133See sourceNot stated by sourceXN06AXF704A001030201444NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20237133See sourceNot stated by sourceXN06AXF704A001030301444NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20237133See sourceNot stated by sourceXN06AXF704A001030401444NHSA

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: 10 filings and 6 distinct first applicants.

Generic 10

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedCYHS2601752Generic2026/07/21Not stated by sourceCDE
Yun Peng Pharmaceuticals Group Co., Ltd. romanizedCYHS2504393Generic2025/12/25Not stated by sourceCDE
Ma Ying Long Pharma Group Co., Ltd. romanizedCYHS2504370Generic2025/12/24Not stated by sourceCDE
Ma Ying Long Pharma Group Co., Ltd. romanizedCYHS2504369Generic2025/12/24Not stated by sourceCDE
Shanghai Gu Fang Meng Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hai Xiang Pharma Co., Ltd. romanizedCYHS2503642Generic2025/10/14Not stated by sourceCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2602652Generic2026/10/29Not stated by sourceCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2602651Generic2026/10/29Not stated by sourceCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2602650Generic2026/10/29Not stated by sourceCDE
Suzhou Di San Pharmaceutical Factory Co., Ltd. romanizedCYHS2602765Generic2026/11/10Not stated by sourceCDE
Suzhou Di San Pharmaceutical Factory Co., Ltd. romanizedCYHS2602764Generic2026/11/10Not stated by sourceCDE
New generic filings in 2026

Loaded records: 6 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedCYHS2601752Generic2026/07/21Not stated by sourceCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2602652Generic2026/10/29Not stated by sourceCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2602651Generic2026/10/29Not stated by sourceCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2602650Generic2026/10/29Not stated by sourceCDE
Suzhou Di San Pharmaceutical Factory Co., Ltd. romanizedCYHS2602765Generic2026/11/10Not stated by sourceCDE
Suzhou Di San Pharmaceutical Factory Co., Ltd. romanizedCYHS2602764Generic2026/11/10Not stated by sourceCDE
API registrations

Non-component matches: 26 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
氢溴酸伏硫西汀 · No verified English nameZhejiang Tian Tai Pharma Co., Ltd. romanizedY20260000296IExact ingredient2026/04/29CDE
乳酸伏硫西汀 · No verified English nameSichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY20250000993ISalt-normalized ingredient2025/10/29CDE
氢溴酸伏硫西汀 · No verified English nameZhejiang Hai Xiang Chuan Nan Pharma Co., Ltd. romanizedY20250000711IExact ingredient2025/07/22CDE
氢溴酸伏硫西汀 · No verified English nameZhejiang Le Pu Pharma Co., Ltd. romanizedY20250000384AExact ingredient2026/09/11CDE
氢溴酸伏硫西汀 · No verified English nameHua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanizedY20250000126AExact ingredient2026/09/29CDE
氢溴酸伏硫西汀 · No verified English nameZhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanizedY20240001365AExact ingredient2026/08/06CDE
氢溴酸伏硫西汀 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20240001098AExact ingredient2026/06/24CDE
氢溴酸伏硫西汀 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20240000098AExact ingredient2026/09/16CDE
氢溴酸伏硫西汀 · No verified English nameAnhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanizedY20240000117AExact ingredient2025/11/19CDE
氢溴酸伏硫西汀 · No verified English nameZhejiang Le Pu Pharma Co., Ltd. romanizedY20230001182AExact ingredient2025/09/04CDE
氢溴酸伏硫西汀 · No verified English nameZhejiang Jiu Zhou Pharma Co., Ltd. romanizedY20230001011AExact ingredient2025/11/02CDE
氢溴酸伏硫西汀 · No verified English nameJiangsu En Hua Pharma Co., Ltd. romanizedY20230000789AExact ingredient2025/01/23CDE
氢溴酸伏硫西汀 · No verified English nameShijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedY20230000555AExact ingredient2026/01/07CDE
氢溴酸伏硫西汀 · No verified English nameHunan Dong Ting Pharma Co., Ltd. romanizedY20230000195AExact ingredient2024/11/07CDE
氢溴酸伏硫西汀 · No verified English nameZhejiang Jing Jin Pharma Co., Ltd. romanizedY20230000034AExact ingredient2026/01/05CDE
氢溴酸伏硫西汀 · No verified English nameBei Da Pharmaceuticals Co., Ltd. romanizedY20230000027AExact ingredient2024/07/17CDE
氢溴酸伏硫西汀 · No verified English nameFujian Sheng Fu Kang Pharma Co., Ltd. romanizedY20220000989AExact ingredient2025/10/10CDE
氢溴酸伏硫西汀 · No verified English nameQian Hui Pharma (Anhui) Co., Ltd. romanizedY20220000103AExact ingredient2024/01/25CDE
氢溴酸伏硫西汀 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20220000116AExact ingredient2025/02/18CDE
氢溴酸伏硫西汀 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20220000238AExact ingredient2025/07/09CDE
氢溴酸伏硫西汀 · No verified English nameShandong Lang Nuo Pharmaceutical Co., Ltd. romanizedY20220000220AExact ingredient2024/10/29CDE
氢溴酸伏硫西汀 · No verified English nameZhongshan Wanhan Pharmaceuticals Co., Ltd.Y20210001265AExact ingredient2026/02/07CDE
氢溴酸伏硫西汀 · No verified English nameShandong Rui Shun Pharma Co., Ltd. romanizedY20210001276AExact ingredient2024/05/09CDE
氢溴酸伏硫西汀 · No verified English nameHetero Labs LimitedY20200001223AExact ingredient2026/03/01CDE
氢溴酸伏硫西汀 · No verified English nameJilin Hui Kang Pharmaceutical Co., Ltd. romanizedY20200000737AExact ingredient2022/10/28CDE
氢溴酸伏硫西汀 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20200000572AExact ingredient2026/05/06CDE
氢溴酸伏硫西汀 · No verified English nameChongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanizedY20200000505AExact ingredient2026/04/30CDE
氢溴酸伏硫西汀 · No verified English nameSichuan Hong Yuan Pharma Co., Ltd. romanizedY20200000548AExact ingredient2026/03/17CDE
氢溴酸伏硫西汀 · No verified English nameJiangsu Hao Sen Pharma Group Co., Ltd. romanizedY20190021303AExact ingredient2026/09/15CDE
氢溴酸伏硫西汀 · No verified English nameLian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY20190000584AExact ingredient2026/02/13CDE
氢溴酸伏硫西汀 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20180001103AExact ingredient2024/08/26CDE
氢溴酸伏硫西汀 · No verified English nameYun Peng Pharmaceuticals Group Co., Ltd. romanizedY20260000905IExact ingredient2026/11/09CDE

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. 2026/11/10Accepted

    Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized

    CYHS2602765

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

    View source ↗
  2. 2026/11/10Accepted

    Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized

    CYHS2602764

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

    View source ↗
  3. 2026/10/29Accepted

    Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized

    CYHS2602652

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  4. 2026/10/29Accepted

    Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized

    CYHS2602651

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  5. 2026/10/29Accepted

    Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized

    CYHS2602650

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    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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