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Brimonidine Tartrate Eye Drops

As of 13 November 2026, for Brimonidine Tartrate Eye Drops, 4 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 2 holders.

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

Listed in the US FDA Orange Book as ALPHAGAN P (NDA 021262, ABBVIE INC).

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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 5 of 6 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: Eye Drops. 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
ALPHAGAN P ABBVIE INC NDA 021262 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 2001/03/16
ALPHAGAN P ABBVIE INC NDA 021770 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 2005/08/19
QOLIANA SANDOZ INC NDA 021764 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 2006/05/22
LUMIFY BAUSCH AND LOMB INC NDA 208144 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN OTC DRUG 2017/12/22
LUMIFY PRESERVATIVE FREE BAUSCH AND LOMB INC NDA 218424 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN OTC DRUG 2024/04/19
ALPHAGAN ALLERGAN INC NDA 020613 · Product no. 001 SOLUTION/DROPS OPHTHALMIC DISCONTINUED 1996/09/06
ALPHAGAN ALLERGAN INC NDA 020490 · Product no. 001 SOLUTION/DROPS OPHTHALMIC DISCONTINUED 1997/03/13

Other dosage forms of the same ingredient

No listings in this group among the displayed brand names.

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: 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, LLCH201604252009/08/190.15%Imported originator drugCDE
Allergan Inc.Allergan Sales, LLCH201604262009/08/190.15%Imported originator drugCDE
Allergan Pharmaceuticals IrelandAllergan Pharmaceuticals IrelandH201606812003/06/025ml:10mgImported originator drugCDE

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
Guangdong Zhong Sheng Pharma Co., Ltd. romanized国药准字H202531210.2%(5ml∶10mg)Category BXS01EAX174G010010100371NHSA
Wuxi Ji Yu Shan He Pharma Co., Ltd. romanized国药准字H200804390.2%(5ml:10mg)Category BXS01EAX174G010010101565NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H202537300.2%(5ml:10mg)Category BXS01EAX174G010010102733NHSA
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized国药准字H200800765ml :10mgCategory BXS01EAX174G010010104010NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H202132790.15%(0.3ml:0.45mg)Category BXS01EAX174G010010104021NHSA
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized国药准字H201632415ml:10mgCategory BXS01EAX174G010010109909NHSA
Sandoz Inc.H201505045ml:10mgCategory BXS01EAX174G010010178196NHSA
AbbVie Inc.国药准字HJ201604260.15%(5ml:7.5mg)Category BXS01EAX174G010010178204NHSA
AbbVie Limited国药准字HJ201606815ml:10mgCategory BXS01EAX174G010010178976NHSA
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H202555130.15%(0.3ml:0.45mg)Category BXS01EAX174G010010180537NHSA
Lu Nan Pharmaceutical Group Co., Ltd. romanized国药准字H202647560.2%(5ml:10mg)Category BXS01EAX174G010010181656NHSA
Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized国药准字H202433470.2%(5ml:10mg)Category BXS01EAX174G010010183124NHSA
Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized国药准字H202532720.2%(5ml:10mg)Category BXS01EAX174G010010183539NHSA
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H20249123See sourceCategory BXS01EAX174G010010183562NHSA
Beijing Nuo Si Lan De Bio Technology Co., Ltd. romanized国药准字H202431520.2%(5ml:10mg)Category BXS01EAX174G010010183698NHSA
Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized国药准字H202437480.2%(5ml:10mg)Category BXS01EAX174G010010184070NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H202543080.2%(5ml:10mg)Category BXS01EAX174G010010184221NHSA
Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized国药准字H202494280.15%(0.3ml:0.45mg)Category BXS01EAX174G010010184458NHSA

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
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2602311Generic2026/09/17Not stated by sourceCDE
Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanizedCYHS2600159Generic2026/01/13Not stated by sourceCDE
Jiangsu Tian Ping Pharma Co., Ltd. romanizedCYHS2602385Generic2026/09/22Not stated by sourceCDE
Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanizedCYHL2600102Generic2026/09/22Not 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
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2602311Generic2026/09/17Not stated by sourceCDE
Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanizedCYHS2600159Generic2026/01/13Not stated by sourceCDE
Jiangsu Tian Ping Pharma Co., Ltd. romanizedCYHS2602385Generic2026/09/22Not stated by sourceCDE
Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanizedCYHL2600102Generic2026/09/22Not stated by sourceCDE
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanizedCYHL2600009Generic2026/01/13Not stated by sourceCDE
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanizedCYHL2600008Generic2026/01/13Not 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 · No verified English nameC-SQUARED PHARMA LIMITEDY20240000181AExact ingredient2026/02/25CDE
酒石酸溴莫尼定 · No verified English nameShijiazhuang Gree Pharmaceutical Co., LtdY20230001184AExact ingredient2026/06/02CDE
酒石酸溴莫尼定 · No verified English nameCZECH-GEN, a.s.Y20210000747AExact ingredient2026/10/16CDE
酒石酸溴莫尼定 · No verified English nameChangzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20190007214AExact ingredient—CDE
酒石酸溴莫尼定 · No verified English nameLu Nan Bei Te Pharmaceutical Co., Ltd. romanizedY20190007183AExact ingredient2025/12/04CDE
酒石酸溴莫尼定 · No verified English nameNanjing Heng Sheng Pharmaceutical Co., Ltd. romanizedY20190007132AExact ingredient—CDE
酒石酸溴莫尼定 · No verified English nameChengdu Xin Yue Pharmaceuticals Co., Ltd. romanizedY20170001125IExact ingredient—CDE
酒石酸溴莫尼定 · No verified English nameIndoco 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: 2026/11/13 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. 2026/11/03Marketing application approved

    Ya Bang Pharmaceuticals Co., Ltd. romanized

    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

    Chengdu Pusch Pharmaceutical Co., Ltd.

    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

    Jiangsu Tian Ping Pharma Co., Ltd. romanized

    CYHS2602385

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

    View source ↗
  4. 2026/09/22Accepted

    Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized

    CYHL2600102

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

    View source ↗
  5. 2026/09/17Accepted

    Jiangsu Fu Bang Pharma Co., Ltd. romanized

    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: 2026/11/13 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.

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