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Timolol Maleate Eye Drops

As of 13 November 2026, for Timolol Maleate Eye Drops, 4 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.

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

Listed in the US FDA Orange Book as TIMOPTIC (NDA 018086, BAUSCH AND LOMB INC).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

Follow for free
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 5 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
TIMOPTIC BAUSCH AND LOMB INC NDA 018086 · Product no. 001, 002 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG Approved prior to 1982 (exact date not listed)
TIMOPTIC IN OCUDOSE BAUSCH AND LOMB INC NDA 019463 · Product no. 001, 002 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 1986/11/05
ISTALOL BAUSCH AND LOMB INC NDA 021516 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 2004/06/04

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
TIMOPTIC-XE BAUSCH AND LOMB INC NDA 020330 · Product no. 001, 002 SOLUTION, GEL FORMING/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 1993/11/04
BLOCADREN MERCK RESEARCH LABORATORIES DIV MERCK CO INC NDA 018017 · Product no. 001, 002, 004 TABLET ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)

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: 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: 33 distinct approval numbers and 25 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangdong Zhong Sheng Pharma Co., Ltd. romanized国药准字H20178006See sourceCategory AXS01EDS008G010010100371NHSA
Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized国药准字H120200545ml:12.5mgCategory AXS01EDS008G010010100928NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H320203775ml:12.5mgCategory AXS01EDS008G010010101510NHSA
Jiangsu Yun Yang Group Pharma Co., Ltd. romanized国药准字H32020313See sourceCategory AXS01EDS008G010010101519NHSA
Jiangsu Yi Hai Pharma Co., Ltd. romanized国药准字H320205355ml:12.5mgCategory AXS01EDS008G010010101730NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H200534590.4ml:1mgCategory AXS01EDS008G010010101791NHSA
Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized国药准字H20065130See sourceCategory AXS01EDS008G010010101840NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H200459475ml:12.5mgCategory AXS01EDS008G010010101967NHSA
Wuhan Wu Jing Pharma Co., Ltd. romanized国药准字H42021078See sourceCategory AXS01EDS008G010010101978NHSA
Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized国药准字H20063099See sourceCategory AXS01EDS008G010010102031NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20243071See sourceCategory AXS01EDS008G010010102733NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20254418See sourceCategory AXS01EDS008G010010102763NHSA
Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized国药准字H200639205ml:25mgCategory AXS01EDS008G010010102817NHSA
Kai Feng Pharmaceutical (Group) Co., Ltd. romanized国药准字H20093786See sourceCategory AXS01EDS008G010010103139NHSA
Changchun Zhang Qing Pharma Group Co., Ltd. romanized国药准字H220204315ml:25mgCategory AXS01EDS008G010010103299NHSA
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized国药准字H200231095ml:25mg;8ml:40mg;10ml:50mgCategory AXS01EDS008G010010104072NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H37022028See sourceCategory AXS01EDS008G010010104127NHSA
Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized国药准字H200454185ml:25mgCategory AXS01EDS008G010010104335NHSA
Hefei Li Fang Pharmaceutical Co., Ltd. romanized国药准字H20253876See sourceCategory AXS01EDS008G010010104394NHSA
Hefei Li Min Pharmaceutical Co., Ltd. romanized国药准字H340227635ml:25mgCategory AXS01EDS008G010010104423NHSA
Ningxia Kang Ya Pharma Co., Ltd. romanized国药准字H200939050.25%Category AXS01EDS008G010010105911NHSA
Jiangsu Yuan Heng Pharma Co., Ltd. romanized国药准字H20249112See sourceCategory AXS01EDS008G010010106033NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20133308See sourceCategory AXS01EDS008G010010107415NHSA
Yang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H20254927See sourceCategory AXS01EDS008G010010181161NHSA
Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized国药准字H120200535ml:25mgCategory AXS01EDS008G010010200928NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H200534590.4ml:1mgCategory AXS01EDS008G010010201791NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H37022028See sourceCategory AXS01EDS008G010010204127NHSA
Yang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H20254927See sourceCategory AXS01EDS008G010010281161NHSA
Guangdong Song Xia Pharma Co., Ltd. romanized国药准字H440240665ml:12.5mgCategory AXS01EDS008G010020100389NHSA
Jiangsu Yi Hai Pharma Co., Ltd. romanized国药准字H320205345ml:25mgCategory AXS01EDS008G010020101730NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H200459485ml:25mgCategory AXS01EDS008G010020101967NHSA
Wuhan Xin Rui Pharmaceuticals Technology Co., Ltd. romanized国药准字H20234367See sourceCategory AXS01EDS008G010020101978NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20243072See sourceCategory AXS01EDS008G010020102733NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20254432See sourceCategory AXS01EDS008G010020102763NHSA
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized国药准字H200231095ml:25mg;8ml:40mg;10ml:50mgCategory AXS01EDS008G010020104072NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H37022028See sourceCategory AXS01EDS008G010020104127NHSA
Jiangsu Yuan Heng Pharma Co., Ltd. romanized国药准字H20249113See sourceCategory AXS01EDS008G010020106033NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20133308See sourceCategory AXS01EDS008G010020107415NHSA
Guangdong Song Xia Pharma Co., Ltd. romanized国药准字H440240675ml:25mgCategory AXS01EDS008G010020200389NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H37022028See sourceCategory AXS01EDS008G010020204127NHSA
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized国药准字H200231095ml:25mg;8ml:40mg;10ml:50mgCategory AXS01EDS008G010030104072NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H37022028See sourceCategory AXS01EDS008G010030104127NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20133308See sourceCategory AXS01EDS008G010030107415NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H37022028See sourceCategory AXS01EDS008G010030204127NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20133308See sourceCategory AXS01EDS008G010040107415NHSA

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 2 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2602494Generic2026/10/12Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2602493Generic2026/10/12Not stated by sourceCDE
Guangdong Nan Guo Pharma Co., Ltd. romanizedCYHS2601324Generic2026/06/08Not stated by sourceCDE
Guangdong Nan Guo Pharma Co., Ltd. romanizedCYHS2502062Generic2025/06/11Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2602494Generic2026/10/12Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2602493Generic2026/10/12Not stated by sourceCDE
Guangdong Nan Guo Pharma Co., Ltd. romanizedCYHS2601324Generic2026/06/08Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
噻吗洛尔半水合物 · No verified English nameHan Rui Pharma (Jing Men) Co., Ltd. romanizedY20260000035ISalt-normalized ingredient2026/01/26CDE
马来酸噻吗洛尔 · No verified English namePCASY20250000663IExact ingredient2025/11/13CDE
马来酸噻吗洛尔 · No verified English nameZhejiang Jiang Bei Nan Hai Pharma Co., Ltd. romanizedY20250000067IExact ingredient2025/05/28CDE
马来酸噻吗洛尔 · No verified English nameTianjin Min Xiang Pharma Co., Ltd. romanizedY20230001317AExact ingredient2025/05/20CDE
马来酸噻吗洛尔 · No verified English nameJiangsu Ci Xing Pharma Co., Ltd. romanizedY20220001347AExact ingredient2024/01/17CDE
马来酸噻吗洛尔 · No verified English nameShijiazhuang Gree Pharmaceutical Co., LtdY20220000253AExact ingredient2024/11/05CDE
马来酸噻吗洛尔 · No verified English nameFareva La ValleeY20190000119AExact ingredient2024/11/07CDE
马来酸噻吗洛尔 · No verified English nameTIANJIN LISHENG PHARMACEUTICAL CO., LTDY20190007964AExact ingredient2025/06/28CDE
马来酸噻吗洛尔 · No verified English nameTianjin Min Xiang Biopharmaceuticals Co., Ltd. romanizedY20170002259AExact ingredient2024/05/01CDE
马来酸噻吗洛尔 · No verified English nameCentaur Pharmaceuticals Private LimitedY20170000577AExact ingredient2024/12/31CDE

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. 2026/10/12Accepted

    Chengdu Pusch Pharmaceutical Co., Ltd.

    CYHS2602494

    Fact date: 2026/10/12 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/10/12Accepted

    Chengdu Pusch Pharmaceutical Co., Ltd.

    CYHS2602493

    Fact date: 2026/10/12 · Site observation date: 2026/10/22

    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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