YaoGeJu

Public drug landscapesDrug landscape

Ondansetron Hydrochloride Tablets

As of 13 November 2026, for Ondansetron Hydrochloride 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 5 holders.

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

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

Follow for free
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: 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
ZOFRAN SANDOZ INC NDA 020103 · Product no. 001, 002 TABLET ORAL DISCONTINUED 1992/12/31
ZOFRAN SANDOZ INC NDA 020103 · Product no. 003 TABLET ORAL DISCONTINUED 1999/08/27

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 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
ZOFRAN SANDOZ INC NDA 020605 · Product no. 001 SOLUTION ORAL DISCONTINUED 1997/01/24

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: 5 holders; 3 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
Bei Da Pharmaceuticals Co., Ltd. romanizedBei Da Pharmaceuticals Co., Ltd. romanized国药准字H109701552025/04/11See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanizedNingbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H202491992024/10/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanizedNingbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H202492002024/10/29See 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H202343682023/10/24See 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H202343692023/10/24See 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H109601462023/02/20See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H109700622019/12/10See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H109700632019/01/16See 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: 11 distinct approval numbers and 7 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Chengdu Tong De Pharma Co., Ltd. romanized国药准字H20263083See sourceCategory AXA04AAA202A001010102068NHSA
Chengdu Tong De Pharma Co., Ltd. romanized国药准字H20263083See sourceCategory AXA04AAA202A001010202068NHSA
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized国药准字H20254887See sourceCategory AXA04AAA202A001010184135NHSA
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized国药准字H20254888See sourceCategory AXA04AAA202A001020184135NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970155See sourceCategory AXA04AAA202A001010100976NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20234368See sourceCategory AXA04AAA202A001010102763NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H10970062See sourceCategory AXA04AAA202A001010104021NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960146See sourceCategory AXA04AAA202A001010104561NHSA
Zhejiang Hao Ge Pharma Co., Ltd. romanized国药准字H20249199See sourceCategory AXA04AAA202A001010184206NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970155See sourceCategory AXA04AAA202A001010200976NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960146See sourceCategory AXA04AAA202A001010204561NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970155See sourceCategory AXA04AAA202A001020100976NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20234369See sourceCategory AXA04AAA202A001020102763NHSA
Zhejiang Hao Ge Pharma Co., Ltd. romanized国药准字H20249200See sourceCategory AXA04AAA202A001020184206NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H10970063See sourceCategory AXA04AAA202A001020204021NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H10970155See sourceCategory AXA04AAA202A001030100976NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20234368See sourceCategory AXA04AAA202A001030102763NHSA
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized国药准字H10960146See sourceCategory AXA04AAA202A001030104561NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20234369See sourceCategory AXA04AAA202A001040102763NHSA

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 6

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Jing Pharma Co., Ltd. romanizedCYHS2601877Generic2026/08/03Not stated by sourceCDE
Nanjing Hai Jing Pharma Co., Ltd. romanizedCYHS2601876Generic2026/08/03Not stated by sourceCDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanizedCYHS2602450Generic2026/10/08Not stated by sourceCDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanizedCYHS2602449Generic2026/10/08Not stated by sourceCDE
CISEN PHARMACEUTICAL CO., LTD.CYHS2503243Generic2025/09/02Not stated by sourceCDE
CISEN PHARMACEUTICAL CO., LTD.CYHS2503242Generic2025/09/02Not 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
Nanjing Hai Jing Pharma Co., Ltd. romanizedCYHS2601877Generic2026/08/03Not stated by sourceCDE
Nanjing Hai Jing Pharma Co., Ltd. romanizedCYHS2601876Generic2026/08/03Not stated by sourceCDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanizedCYHS2602450Generic2026/10/08Not stated by sourceCDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanizedCYHS2602449Generic2026/10/08Not 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. 2026/10/08Accepted

    Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized

    CYHS2602450

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

    View source ↗
  2. 2026/10/08Accepted

    Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized

    CYHS2602449

    Fact date: 2026/10/08 · 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.

Free follow

Follow changes to Ondansetron Hydrochloride Tablets

Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.

Confirmation links expire in 7 days. No digest is sent before confirmation; existing follows are not duplicated.

Sign in to choose products