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Sulindac Tablets(舒林酸片)

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

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

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Complete CDE snapshot
2026/11/10 07:27
Matching scope
Same generic name; dosage forms and combinations kept separate

Which companies are listed, and at what stages?

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

Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.

Chemical-drug catalogue

Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
浙江皓格药业有限公司成都通德药业有限公司 国药准字H20263746 2026/03/31 0.2g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
福安药业集团庆余堂制药有限公司福安药业集团庆余堂制药有限公司 国药准字H20263794 2026/03/31 0.1g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
福安药业集团庆余堂制药有限公司福安药业集团庆余堂制药有限公司 国药准字H20263793 2026/03/31 0.2g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
甘正(海南)生物药业有限公司海南科进生物制药有限公司 国药准字H20263418 2026/02/10 0.2g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
甘正(海南)生物药业有限公司海南科进生物制药有限公司 国药准字H20263419 2026/02/10 0.15g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
沐源(安徽)药业有限公司华益药业科技(安徽)有限公司 国药准字H20263315 2026/02/02 0.2g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE

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: 9 distinct approval numbers and 7 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
福安药业集团庆余堂制药有限公司 国药准字H20263793 0.2g Category B (乙) XM01ABS092A001010101877NHSA
青岛国信制药有限公司 国药准字H20033535 0.1g Category B (乙) XM01ABS092A001010104036NHSA
宁波大红鹰药业股份有限公司 国药准字H10940091 0.1g Category B (乙) XM01ABS092A001010104554NHSA
福安药业集团宁波天衡制药有限公司 国药准字H33021627 0.1g Category B (乙) XM01ABS092A001010104561NHSA
海南科进生物制药有限公司 国药准字H20263419 0.15g Category B (乙) XM01ABS092A001010105819NHSA
浙江皓格药业有限公司 国药准字H20263746 0.2g Category B (乙) XM01ABS092A001010183726NHSA
沐源(安徽)药业有限公司 国药准字H20263315 0.2g Category B (乙) XM01ABS092A001010184519NHSA
青岛国信制药有限公司 国药准字H20033535 0.1g Category B (乙) XM01ABS092A001010204036NHSA
福安药业集团宁波天衡制药有限公司 国药准字H33021627 0.1g Category B (乙) XM01ABS092A001010204561NHSA
海南科进生物制药有限公司 国药准字H20263419 0.15g Category B (乙) XM01ABS092A001010205819NHSA
浙江皓格药业有限公司 国药准字H20263746 0.2g Category B (乙) XM01ABS092A001010283726NHSA
沐源(安徽)药业有限公司 国药准字H20263315 0.2g Category B (乙) XM01ABS092A001010284519NHSA
青岛国信制药有限公司 国药准字H20033535 0.1g Category B (乙) XM01ABS092A001010304036NHSA
福安药业集团宁波天衡制药有限公司 国药准字H33021627 0.1g Category B (乙) XM01ABS092A001010304561NHSA
海南科进生物制药有限公司 国药准字H20263419 0.15g Category B (乙) XM01ABS092A001010305819NHSA
沐源(安徽)药业有限公司 国药准字H20263315 0.2g Category B (乙) XM01ABS092A001010384519NHSA
青岛国信制药有限公司 国药准字H20033535 0.1g Category B (乙) XM01ABS092A001010404036NHSA
福安药业集团庆余堂制药有限公司 国药准字H20263794 0.1g Category B (乙) XM01ABS092A001020101877NHSA
宁波大红鹰药业股份有限公司 国药准字H10940091 0.1g Category B (乙) XM01ABS092A001020104554NHSA
海南科进生物制药有限公司 国药准字H20263418 0.2g Category B (乙) XM01ABS092A001020105819NHSA
宁波大红鹰药业股份有限公司 国药准字H10940091 0.1g Category B (乙) XM01ABS092A001020204554NHSA
海南科进生物制药有限公司 国药准字H20263418 0.2g Category B (乙) XM01ABS092A001020205819NHSA
海南科进生物制药有限公司 国药准字H20263418 0.2g Category B (乙) XM01ABS092A001020305819NHSA

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 3 distinct first applicants.

Generic 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
江苏万高药业股份有限公司 CYHS2602279 Generic2026/09/15Not stated by sourceCDE
江苏万高药业股份有限公司 CYHS2602278 Generic2026/09/15Not stated by sourceCDE
苏州朗科生物技术股份有限公司;成都通德药业有限公司 CYHS2503125 Generic2025/08/26Not stated by sourceCDE
江苏东科康德药业有限公司;广东星昊药业有限公司 CYHS2600077 Generic2026/01/08Not stated by sourceCDE
江苏东科康德药业有限公司;广东星昊药业有限公司 CYHS2600076 Generic2026/01/08Not 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
江苏万高药业股份有限公司 CYHS2602279 Generic2026/09/15Not stated by sourceCDE
江苏万高药业股份有限公司 CYHS2602278 Generic2026/09/15Not stated by sourceCDE
江苏东科康德药业有限公司;广东星昊药业有限公司 CYHS2600077 Generic2026/01/08Not stated by sourceCDE
江苏东科康德药业有限公司;广东星昊药业有限公司 CYHS2600076 Generic2026/01/08Not stated by sourceCDE
API registrations

Non-component matches: 4 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
舒林酸安徽修一制药有限公司Y20260000142IExact ingredient2026/03/06CDE
舒林酸杭州福斯特药业有限公司Y20240001431AExact ingredient2026/08/13CDE
舒林酸江苏诺泰澳赛诺生物制药股份有限公司Y20230001372AExact ingredient2026/07/09CDE
舒林酸宁波大红鹰药业股份有限公司Y20190002461AExact ingredient2025/01/03CDE
舒林酸福安药业集团宁波天衡制药有限公司Y20190001705AExact ingredient2025/02/20CDE

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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

  1. 2026/09/15Accepted

    江苏万高药业股份有限公司

    CYHS2602279

    Fact date: 2026/09/15 · Site observation date: 2026/10/21

    View source ↗
  2. 2026/09/15Accepted

    江苏万高药业股份有限公司

    CYHS2602278

    Fact date: 2026/09/15 · Site observation date: 2026/10/21

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/10 07:27
Chemical-drug catalogue
Last successful update: 2026/11/10 07:23

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: 2026/11/10 07:25
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: 2026/11/10 18:31

First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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