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Brimonidine Tartrate Eye Drops(酒石酸溴莫尼定滴眼液)

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

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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: 2 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
Allergan Inc.Allergan Sales, LLC H20160425 2009/08/19 0.15% Imported originator drug (进口原研药品) CDE
Allergan Inc.Allergan Sales, LLC H20160426 2009/08/19 0.15% Imported originator drug (进口原研药品) CDE
Allergan Pharmaceuticals IrelandAllergan Pharmaceuticals Ireland H20160681 2003/06/02 5ml:10mg 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: 18 distinct approval numbers and 18 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
广东众生药业股份有限公司 国药准字H20253121 0.2%(5ml∶10mg) Category B (乙) XS01EAX174G010010100371NHSA
无锡济煜山禾药业股份有限公司 国药准字H20080439 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010101565NHSA
石家庄格瑞药业有限公司 国药准字H20253730 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010102733NHSA
鲁南贝特制药有限公司 国药准字H20080076 5ml :10mg Category B (乙) XS01EAX174G010010104010NHSA
齐鲁制药有限公司 国药准字H20213279 0.15%(0.3ml:0.45mg) Category B (乙) XS01EAX174G010010104021NHSA
北京汇恩兰德制药股份有限公司 国药准字H20163241 5ml:10mg Category B (乙) XS01EAX174G010010109909NHSA
Sandoz Inc. H20150504 5ml:10mg Category B (乙) XS01EAX174G010010178196NHSA
AbbVie Inc. 国药准字HJ20160426 0.15%(5ml:7.5mg) Category B (乙) XS01EAX174G010010178204NHSA
AbbVie Limited 国药准字HJ20160681 5ml:10mg Category B (乙) XS01EAX174G010010178976NHSA
南京海纳制药有限公司 国药准字H20255513 0.15%(0.3ml:0.45mg) Category B (乙) XS01EAX174G010010180537NHSA
鲁南制药集团股份有限公司 国药准字H20264756 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010181656NHSA
山东威智百科药业有限公司 国药准字H20243347 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010183124NHSA
汕头经济特区明治医药有限公司 国药准字H20253272 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010183539NHSA
苏州欧康维视生物科技有限公司 国药准字H20249123 0.2%(5ml:10mg,按C₁₁H₁₀BrN₅·C₄H₆O₆计) Category B (乙) XS01EAX174G010010183562NHSA
北京诺思兰德生物技术股份有限公司 国药准字H20243152 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010183698NHSA
艾尔健康眼药(辽宁)有限公司 国药准字H20243748 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010184070NHSA
浙江高跖医药科技股份有限公司 国药准字H20254308 0.2%(5ml:10mg) Category B (乙) XS01EAX174G010010184221NHSA
四川智强医药科技开发有限公司 国药准字H20249428 0.15%(0.3ml:0.45mg) Category B (乙) XS01EAX174G010010184458NHSA

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
江苏福邦药业有限公司 CYHS2602311 Generic2026/09/17Not stated by sourceCDE
复星医药(徐州)有限公司 CYHS2600159 Generic2026/01/13Not stated by sourceCDE
江苏天平药业有限公司 CYHS2602385 Generic2026/09/22Not stated by sourceCDE
大邦(湖南)生物制药有限公司 CYHL2600102 Generic2026/09/22Not stated by sourceCDE
New generic filings in 2026

Loaded records: 6 filings and 5 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
江苏福邦药业有限公司 CYHS2602311 Generic2026/09/17Not stated by sourceCDE
复星医药(徐州)有限公司 CYHS2600159 Generic2026/01/13Not stated by sourceCDE
江苏天平药业有限公司 CYHS2602385 Generic2026/09/22Not stated by sourceCDE
大邦(湖南)生物制药有限公司 CYHL2600102 Generic2026/09/22Not stated by sourceCDE
北京汇恩兰德制药股份有限公司 CYHL2600009 Generic2026/01/13Not stated by sourceCDE
北京汇恩兰德制药股份有限公司 CYHL2600008 Generic2026/01/13Not stated by sourceCDE
API registrations

Non-component matches: 7 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
酒石酸溴莫尼定C-SQUARED PHARMA LIMITEDY20240000181AExact ingredient2026/02/25CDE
酒石酸溴莫尼定石家庄格瑞药业有限公司Y20230001184AExact ingredient2026/06/02CDE
酒石酸溴莫尼定CZECH-GEN, a.s.Y20210000747AExact ingredient2026/10/16CDE
酒石酸溴莫尼定常州亚邦制药有限公司Y20190007214AExact ingredient—CDE
酒石酸溴莫尼定鲁南贝特制药有限公司Y20190007183AExact ingredient2025/12/04CDE
酒石酸溴莫尼定南京恒生制药有限公司Y20190007132AExact ingredient—CDE
酒石酸溴莫尼定成都新越医药有限公司Y20170001125IExact ingredient—CDE
酒石酸溴莫尼定Indoco Remedies Ltd. (Kilo Lab)Y20170000909AExact ingredient2026/04/02CDE

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. 2026/11/03Marketing application approved

    亚邦医药股份有限公司

    CYHS2501496 · 国药准字H20266463

    Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06

    The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.

    View source · Table row 54 ↗
  2. 2026/10/27No longer listed under review

    成都普什制药有限公司

    CYHS2502464

    Fact date: 2026/10/27 · Site observation date: 2026/10/27

    Accepted: 2025/07/11

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  3. 2026/09/22Accepted

    江苏天平药业有限公司

    CYHS2602385

    Fact date: 2026/09/22 · Site observation date: 2026/10/21

    View source ↗
  4. 2026/09/22Accepted

    大邦(湖南)生物制药有限公司

    CYHL2600102

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

    View source ↗
  5. 2026/09/17Accepted

    江苏福邦药业有限公司

    CYHS2602311

    Fact date: 2026/09/17 · 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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