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Flupentixol and Melitracen Tablets(氟哌噻吨美利曲辛片)

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
2026/11/10 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: 6 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
成都倍特药业股份有限公司成都倍特药业股份有限公司 国药准字H20254485 2025/06/10 每片含氟哌噻吨0.5mg和美利曲辛10mg 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
植恩生物技术股份有限公司植恩生物技术股份有限公司 国药准字H20249160 2024/10/22 每片含氟哌噻吨0.5mg和美利曲辛10mg 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
重庆圣华曦药业股份有限公司重庆圣华曦药业股份有限公司 国药准字H20153122 2021/11/09 每片含氟哌噻吨0.5mg和美利曲辛10mg Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
海南辉能药业有限公司海南辉能药业有限公司 国药准字H20143390 2021/06/28 每片含氟哌噻吨0.5mg和美利曲辛10mg Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
四川海思科制药有限公司四川海思科制药有限公司 国药准字H20153014 2019/02/19 本品为复方制剂,每片含氟哌噻吨0.5mg和美利曲辛10mg Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
H.Lundbeck A/SH.Lundbeck A/S H20171104 1999/09/17 氟哌噻吨0.5mg和美利曲辛10mg/片 Imported originator drug (进口原研药品) 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: 6 distinct approval numbers and 6 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
成都倍特药业股份有限公司 国药准字H20254485 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010102013NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010109568NHSA
植恩生物技术股份有限公司 国药准字H20249160 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010109642NHSA
H.Lundbeck A/S 国药准字HJ20171104 氟哌噻吨0.5mg和美利曲辛10mg/片 Category B (乙) XN06CAF088A001010178996NHSA
四川海思科制药有限公司 国药准字H20153014 本品为复方制剂,每片含氟哌噻吨0.5mg 和美利曲辛10mg Category B (乙) XN06CAF088A001010179282NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010209568NHSA
四川海思科制药有限公司 国药准字H20153014 本品为复方制剂,每片含氟哌噻吨0.5mg 和美利曲辛10mg Category B (乙) XN06CAF088A001010279282NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010309568NHSA
四川海思科制药有限公司 国药准字H20153014 本品为复方制剂,每片含氟哌噻吨0.5mg 和美利曲辛10mg Category B (乙) XN06CAF088A001010379282NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010409568NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010509568NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010609568NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010709568NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010809568NHSA
重庆圣华曦药业股份有限公司 国药准字H20153122 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001010909568NHSA
海南辉能药业有限公司 国药准字H20143390 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001020105836NHSA
海南辉能药业有限公司 国药准字H20143390 每片含氟哌噻吨0.5mg和美利曲辛10mg Category B (乙) XN06CAF088A001020205836NHSA

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: 4 filings and 4 distinct first applicants.

Import re-registration 1 · Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
H. Lundbeck A/S JYHZ2600168 Import re-registration2026/07/10Not stated by sourceCDE
远大医药(西安)有限公司;西安远大德天药业股份有限公司 CYHS2601532 Generic2026/06/29Not stated by sourceCDE
广东健信制药股份有限公司;汕头经济特区鮀滨制药厂 CYHS2502245 Generic2025/06/23Not stated by sourceCDE
南京正大天晴制药有限公司 CYHS2602677 Generic2026/11/02Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
远大医药(西安)有限公司;西安远大德天药业股份有限公司 CYHS2601532 Generic2026/06/29Not stated by sourceCDE
南京正大天晴制药有限公司 CYHS2602677 Generic2026/11/02Not stated by sourceCDE
API registrations

Non-component matches: 0 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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. 2026/11/02Accepted

    南京正大天晴制药有限公司

    CYHS2602677

    Fact date: 2026/11/02 · Site observation date: 2026/11/03

    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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