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盐酸奥洛他定口崩片

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

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 0 distinct approval numbers and 0 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
宏越科技(湖州)有限公司;浙江皓格药业有限公司 CYHS2602266 Generic2026/09/10Not stated by sourceCDE
海南元盈医药科技有限公司;天津汉瑞药业有限公司 CYHS2601723 Generic2026/07/20Not stated by sourceCDE
海南科进生物制药有限公司 CYHS2601670 Generic2026/07/13Not stated by sourceCDE
江西施美药业股份有限公司 CYHS2600294 Generic2026/01/29Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
宏越科技(湖州)有限公司;浙江皓格药业有限公司 CYHS2602266 Generic2026/09/10Not stated by sourceCDE
海南元盈医药科技有限公司;天津汉瑞药业有限公司 CYHS2601723 Generic2026/07/20Not stated by sourceCDE
海南科进生物制药有限公司 CYHS2601670 Generic2026/07/13Not stated by sourceCDE
江西施美药业股份有限公司 CYHS2600294 Generic2026/01/29Not stated by sourceCDE
API registrations

Non-component matches: 16 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
盐酸奥洛他定Precise Biopharma Pvt LtdY20240001453IExact ingredient2025/10/16CDE
盐酸奥洛他定石家庄格瑞药业有限公司Y20230000466AExact ingredient2025/09/29CDE
盐酸奥洛他定新乡海滨药业有限公司Y20220001158AExact ingredient2024/06/21CDE
盐酸奥洛他定江苏迪赛诺制药有限公司Y20200001291AExact ingredient2023/01/04CDE
盐酸奥洛他定四川子仁制药有限公司Y20200000735AExact ingredient2022/10/28CDE
盐酸奥洛他定河北创健药业有限公司Y20200000675AExact ingredient2024/02/21CDE
盐酸奥洛他定CURIA SPAIN S.A.U.Y20190009103AExact ingredient2026/10/14CDE
盐酸奥洛他定CRYSTAL PHARMA S.A.U.Y20190009102AExact ingredient—CDE
盐酸奥洛他定Kyowa Hakko Kirin Co.,Ltd.Y20190009080AExact ingredient—CDE
盐酸奥洛他定重庆西南制药二厂有限责任公司Y20190008886AExact ingredient—CDE
盐酸奥洛他定常州亚邦制药有限公司Y20190008405AExact ingredient2024/08/29CDE
盐酸奥洛他定武邑慈航药业有限公司Y20190007169AExact ingredient2023/03/24CDE
盐酸奥洛他定齐鲁制药有限公司Y20190006800AExact ingredient—CDE
盐酸奥洛他定晋城海斯制药有限公司Y20170001002AExact ingredient2023/05/16CDE
盐酸奥洛他定PCAS Finland OyY20170000692AExact ingredient2024/10/29CDE
盐酸奥洛他定MSN Laboratories Private LimitedY20170000299AExact ingredient2024/12/31CDE
盐酸奥洛他定重庆胜凯制药有限公司Y20170000273AExact ingredient2025/04/22CDE

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. 2026/09/10Accepted

    宏越科技(湖州)有限公司;浙江皓格药业有限公司

    CYHS2602266

    Fact date: 2026/09/10 · Site observation date: 2026/10/22

    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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