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Public drug landscapesDrug landscape

Ondansetron Hydrochloride Injection

As of 13 November 2026, for Ondansetron Hydrochloride Injection, 5 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 9 holders.

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

Last 90 days: Accepted: 1 application

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 3 of 3 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: Injection. 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
ZOFRAN SANDOZ INC NDA 020007 · Product no. 001 INJECTABLE INJECTION DISCONTINUED 1991/01/04
ZOFRAN PRESERVATIVE FREE SANDOZ INC NDA 020007 · Product no. 003 INJECTABLE INJECTION DISCONTINUED 1993/12/10
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER GLAXOSMITHKLINE NDA 020403 · Product no. 001 INJECTABLE INJECTION DISCONTINUED 1995/01/31

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
ZOFRAN SANDOZ INC NDA 020103 · Product no. 001, 002 TABLET ORAL DISCONTINUED 1992/12/31
ZOFRAN SANDOZ INC NDA 020605 · Product no. 001 SOLUTION ORAL DISCONTINUED 1997/01/24
ZOFRAN SANDOZ INC NDA 020103 · Product no. 003 TABLET ORAL DISCONTINUED 1999/08/27

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: 9 holders; 7 in the quality-and-efficacy consistency-evaluation category, and 2 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Rui Yang Pharmaceutical Co., Ltd. romanizedRui Yang Pharmaceutical Co., Ltd. romanized国药准字H200547042026/04/16See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H200672422025/09/22See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H200672412025/09/22See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H200459842024/07/17See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H200837592024/07/17See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202437512024/05/21See 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H202437502024/05/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H200593592021/10/15See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanizedBeijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H202137442021/09/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanizedBeijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H202137432021/09/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanizedFu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H109601482021/06/16See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Qilu Pharmaceutical (Hainan) Co., LtdQilu Pharmaceutical (Hainan) Co., Ltd国药准字H200931822021/01/28See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H109700642021/01/27See sourceNot stated by sourceCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H109700652021/01/27See sourceDrug that passed quality-and-efficacy consistency evaluationCDE

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: 51 distinct approval numbers and 30 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H20213743See sourceCategory BXA04AAA202B002010100123NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200664742ml:4mgCategory BXA04AAA202B002010100526NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970179See sourceCategory BXA04AAA202B002010100976NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055086See sourceCategory BXA04AAA202B002010101017NHSA
Liaoning Tian Long Pharma Co., Ltd. romanized国药准字H20056409See sourceCategory BXA04AAA202B002010101237NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H200464932ml:4mgCategory BXA04AAA202B002010101511NHSA
Chengdu Ping Yuan Pharma Co., Ltd. romanized国药准字H20059328See sourceCategory BXA04AAA202B002010102027NHSA
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H20046058See sourceCategory BXA04AAA202B002010102044NHSA
Chengdu Ping Yuan Pharma Co., Ltd. romanized国药准字H20059329See sourceCategory BXA04AAA202B002010102050NHSA
Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized国药准字H20053255See sourceCategory BXA04AAA202B002010102129NHSA
Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H20045984See sourceCategory BXA04AAA202B002010102189NHSA
Shaanxi Kai Yuan Pharmaceutical Co., Ltd. romanized国药准字H20065286See sourceCategory BXA04AAA202B002010102394NHSA
Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized国药准字H20059084See sourceCategory BXA04AAA202B002010102557NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20243750See sourceCategory BXA04AAA202B002010102763NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20059317See sourceCategory BXA04AAA202B002010103421NHSA
Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized国药准字H20053855See sourceCategory BXA04AAA202B002010103458NHSA
Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized国药准字H20054309See sourceCategory BXA04AAA202B002010103488NHSA
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20059290See sourceCategory BXA04AAA202B002010103662NHSA
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H20054696See sourceCategory BXA04AAA202B002010103973NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H10970065See sourceCategory BXA04AAA202B002010104021NHSA
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H20073245See sourceCategory BXA04AAA202B002010104069NHSA
Shandong Feng Huang Pharmaceutical Co., Ltd. romanized国药准字H20055769See sourceCategory BXA04AAA202B002010104085NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067241See sourceCategory BXA04AAA202B002010104127NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20054704See sourceCategory BXA04AAA202B002010104152NHSA
Shandong Yi Kang Pharma Co., Ltd. romanized国药准字H20054892See sourceCategory BXA04AAA202B002010104193NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20063029See sourceCategory BXA04AAA202B002010104207NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960149See sourceCategory BXA04AAA202B002010104561NHSA
Jiangxi Run Ze Pharma Co., Ltd. romanized国药准字H20067340See sourceCategory BXA04AAA202B002010105303NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H200931712ml:4mgCategory BXA04AAA202B002010105791NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20093182See sourceCategory BXA04AAA202B002010105847NHSA
Novartis Pharma Schweiz AGH201703154ml:8mgCategory BXA04AAA202B002010178679NHSA
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H20213743See sourceCategory BXA04AAA202B002010200123NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200664742ml:4mgCategory BXA04AAA202B002010200526NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970179See sourceCategory BXA04AAA202B002010200976NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055086See sourceCategory BXA04AAA202B002010201017NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H200464932ml:4mgCategory BXA04AAA202B002010201511NHSA
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H20046058See sourceCategory BXA04AAA202B002010202044NHSA
Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized国药准字H20059084See sourceCategory BXA04AAA202B002010202557NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20243750See sourceCategory BXA04AAA202B002010202763NHSA
Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized国药准字H20053855See sourceCategory BXA04AAA202B002010203458NHSA
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20059290See sourceCategory BXA04AAA202B002010203662NHSA
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H20054696See sourceCategory BXA04AAA202B002010203973NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H10970065See sourceCategory BXA04AAA202B002010204021NHSA
Shandong Feng Huang Pharmaceutical Co., Ltd. romanized国药准字H20055769See sourceCategory BXA04AAA202B002010204085NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067241See sourceCategory BXA04AAA202B002010204127NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20054704See sourceCategory BXA04AAA202B002010204152NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20063029See sourceCategory BXA04AAA202B002010204207NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960149See sourceCategory BXA04AAA202B002010204561NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H200931712ml:4mgCategory BXA04AAA202B002010205791NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20093182See sourceCategory BXA04AAA202B002010205847NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067241See sourceCategory BXA04AAA202B002010304127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067241See sourceCategory BXA04AAA202B002010404127NHSA
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H20213744See sourceCategory BXA04AAA202B002020100123NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200664754ml:8mgCategory BXA04AAA202B002020100526NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970180See sourceCategory BXA04AAA202B002020100976NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055087See sourceCategory BXA04AAA202B002020101017NHSA
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H20046059See sourceCategory BXA04AAA202B002020102044NHSA
Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H20083759See sourceCategory BXA04AAA202B002020102189NHSA
Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized国药准字H20059083See sourceCategory BXA04AAA202B002020102557NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20243751See sourceCategory BXA04AAA202B002020102763NHSA
Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized国药准字H20053856See sourceCategory BXA04AAA202B002020103458NHSA
Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized国药准字H20054310See sourceCategory BXA04AAA202B002020103488NHSA
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20059359See sourceCategory BXA04AAA202B002020103662NHSA
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H20054697See sourceCategory BXA04AAA202B002020103973NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H10970064See sourceCategory BXA04AAA202B002020104021NHSA
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H20073245See sourceCategory BXA04AAA202B002020104069NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067242See sourceCategory BXA04AAA202B002020104127NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20063028See sourceCategory BXA04AAA202B002020104207NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960148See sourceCategory BXA04AAA202B002020104561NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H200931724ml:8mgCategory BXA04AAA202B002020105791NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20093183See sourceCategory BXA04AAA202B002020105847NHSA
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H20213744See sourceCategory BXA04AAA202B002020200123NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200664754ml:8mgCategory BXA04AAA202B002020200526NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970180See sourceCategory BXA04AAA202B002020200976NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055087See sourceCategory BXA04AAA202B002020201017NHSA
Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized国药准字H20059083See sourceCategory BXA04AAA202B002020202557NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20243751See sourceCategory BXA04AAA202B002020202763NHSA
Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized国药准字H20053856See sourceCategory BXA04AAA202B002020203458NHSA
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20059359See sourceCategory BXA04AAA202B002020203662NHSA
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H20054697See sourceCategory BXA04AAA202B002020203973NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H10970064See sourceCategory BXA04AAA202B002020204021NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067242See sourceCategory BXA04AAA202B002020204127NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20063028See sourceCategory BXA04AAA202B002020204207NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960148See sourceCategory BXA04AAA202B002020204561NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H200931724ml:8mgCategory BXA04AAA202B002020205791NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20093183See sourceCategory BXA04AAA202B002020205847NHSA
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20059359See sourceCategory BXA04AAA202B002020303662NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067242See sourceCategory BXA04AAA202B002020304127NHSA
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20059359See sourceCategory BXA04AAA202B002020403662NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20067242See sourceCategory BXA04AAA202B002020404127NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055086See sourceCategory BXA04AAA202B002030101017NHSA
Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H20083759See sourceCategory BXA04AAA202B002030102189NHSA
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H20063167See sourceCategory BXA04AAA202B002030104069NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055086See sourceCategory BXA04AAA202B002030201017NHSA
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H20063167See sourceCategory BXA04AAA202B002030204069NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055087See sourceCategory BXA04AAA202B002040101017NHSA
Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H20045984See sourceCategory BXA04AAA202B002040102189NHSA
Chongqing Lai Mei Pharma Co., Ltd. romanized国药准字H20055087See sourceCategory BXA04AAA202B002040201017NHSA
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H20063166See sourceCategory BXA04AAA202B002040204069NHSA
Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H20063166See sourceCategory BXA04AAA202B002040304069NHSA

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: 5 filings and 4 distinct first applicants.

Generic 4 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedCYHS2601824Generic2026/07/29Not stated by sourceCDE
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedCYHS2601823Generic2026/07/29Not stated by sourceCDE
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanizedCYHB2650013Supplement2026/01/13Not stated by sourceCDE
Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2504236Generic2025/12/10Not stated by sourceCDE
Shanghai He Feng Pharmaceutical Co., Ltd. romanizedCYHS2602687Generic2026/11/03Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedCYHS2601824Generic2026/07/29Not stated by sourceCDE
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedCYHS2601823Generic2026/07/29Not stated by sourceCDE
Shanghai He Feng Pharmaceutical Co., Ltd. romanizedCYHS2602687Generic2026/11/03Not stated by sourceCDE
API registrations

Non-component matches: 13 companies with A status and 5 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸昂丹司琼 · No verified English nameSichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanizedY20250000969IExact ingredient2025/09/19CDE
昂丹司琼 · No verified English nameSichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanizedY20250000968ISalt-normalized ingredient2025/09/19CDE
盐酸昂丹司琼 · No verified English nameSichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY20250000593AExact ingredient2026/10/16CDE
昂丹司琼 · No verified English nameShodhana Laboratories Private LimitedY20250000166ISalt-normalized ingredient2025/04/03CDE
昂丹司琼 · No verified English nameHIKAL LIMITEDY20230000886ISalt-normalized ingredient2024/01/30CDE
昂丹司琼 · No verified English nameSichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY20230000303ASalt-normalized ingredient2026/06/16CDE
昂丹司琼 · No verified English nameDr. Reddy's Laboratories Ltd.Y20220001178ASalt-normalized ingredient2025/08/28CDE
盐酸昂丹司琼 · No verified English nameLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY20220000619AExact ingredient2025/05/09CDE
盐酸昂丹司琼 · No verified English nameApitoria Pharma Private LimitedY20210000190AExact ingredient2025/07/15CDE
盐酸昂丹司琼 · No verified English nameNatco Pharma LimitedY20200000836AExact ingredient2024/01/31CDE
盐酸昂丹司琼 · No verified English nameDr. Reddy's Laboratories Ltd.Y20200000931AExact ingredient2026/05/20CDE
昂丹司琼 · No verified English nameJiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY20190021613ASalt-normalized ingredient2026/08/20CDE
盐酸昂丹司琼 · No verified English nameFu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanizedY20190009491AExact ingredient—CDE
盐酸昂丹司琼 · No verified English nameSichuan Chuan Da Hua Xi Pharma Co., Ltd. romanizedY20190006261AExact ingredient—CDE
盐酸昂丹司琼 · No verified English nameHainan Xian Sheng Pharma Co., Ltd. romanizedY20190006208AExact ingredient2024/06/28CDE
盐酸昂丹司琼 · No verified English nameChangzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20190004948AExact ingredient2025/08/30CDE
盐酸昂丹司琼 · No verified English nameChangzhou Lan Ling Pharmaceutical Co., Ltd. romanizedY20190003744AExact ingredient2025/07/18CDE
盐酸昂丹司琼 · No verified English nameBei Da Pharmaceuticals Co., Ltd. romanizedY20190002237AExact ingredient2025/09/01CDE
盐酸昂丹司琼 · No verified English nameQilu Pharmaceutical Co., Ltd.Y20190001571AExact ingredient2024/11/21CDE
盐酸昂丹司琼(工艺2) · No verified English nameQilu Pharmaceutical Co., Ltd.Y20180001627IExact ingredient2019/02/03CDE
盐酸昂丹司琼 · No verified English nameQilu Pharmaceutical Co., Ltd.Y20180001049AExact ingredient2025/07/18CDE
盐酸昂丹司琼 · No verified English nameFu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanizedY20170002166AExact ingredient2025/01/25CDE

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. 2026/11/03Accepted

    Shanghai He Feng Pharmaceutical Co., Ltd. romanized

    CYHS2602687

    Fact date: 2026/11/03 · Site observation date: 2026/11/04

    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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